MAY 2005
WEEK ENDING MAY 7
PRODUCT
Clostridium Botulinum Toxin Type A. Each vial contains 5.Ong stabilized toxin;
500 IU (LD50 mouse units), labeled, For Research Purposes Only, Not For Human
Use.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Toxin Research International AKA TRI, Tucson, AR
REASON
Unapproved New Drug.
VOLUME OF PRODUCT IN COMMERCE
1,831.
DISTRIBUTION
Nationwide and Canada.
PRODUCT Oncaspar, 1 unit dose per unit package, BLA STN 103411, 750 I.U. per
mL, Sterile,
NDC 57665-002-02.
CODE
Lot number: AC0408 Exp. Date: 3/16/2006.
RECALLING FIRM
Enzon Pharmaceuticals, Inc., South Plainfield, NJ
REASON
Superpotent Increase or potential of increase in enzymatic activity in vitro
above specification before expiry date.
VOLUME OF PRODUCT IN COMMERCE
2,203 vials.
DISTRIBUTION
Nationwide.
PRODUCT
Gas-X with Maalox Extra Strength Antigas plus Antiacid (Calcium Carbonate 500mg
and Simethicone 125mg), 24 count blister package. NDC 0067-0130-24.
CODE
Lot numbers: 98207, 98208, 98209, 98236, 98237, 98246 all expiration date Sept.
30, 2006.
RECALLING FIRM/MANUFACTURER
Novartis Consumer Health Care, Carolina, PR
REASON
Microbial test specification failure; (Staphylococcus aureus).
VOLUME OF PRODUCT IN COMMERCE
90,000 blister packs.
DISTRIBUTION
Nationwide.
PRODUCT
a) Prochlorperazine Suppositories, USP, 2.5mg,
12 count package, Pediatric-Size Suppositories,
Rx Only, For Rectal Use Only, NDC 53265-243-12.
b) Prochlorperazine Suppositories, 5mg,
12 count package, For Older Children (Not under
40 lbs.) Rx Only, For Rectal Use Only,
NDC 53265-244-12.
CODE
a) Lot 308029A, 7/31/2005;
b) Lot 308030A, 7/31/2005.
RECALLING FIRM
Able Laboratories, Inc., South Plainfield, NJ
REASON
Impurity failures (18 month).
VOLUME OF PRODUCT IN COMMERCE
5,681 -- 2.5mg and 23,159 -- 5mg.
DISTRIBUTION
Nationwide.
PRODUCT
Fougera Betamethasone Dipropionate Ointment USP, 0.05% (Potency expressed as
betamethasone), net wt 45 grams, Rx only, NDC 0168-0056-46. Product is a topical
ointment which is packed in a tube and packaged in a unit carton.
CODE
Lot N085, Exp. Date 12/06.
RECALLING FIRM/MANUFACTURER Altana, Inc., Melville, NY
REASON Superpotent: out-of-specification stability test result of 113.9% for the betamethasone
dipropionate assay at 12-month time point.
VOLUME OF PRODUCT IN COMMERCE
42,090 units.
DISTRIBUTION
Nationwide and PR.
PRODUCT
Trecator SC Tablets (ethionamide), 250 mg, Sugar-Coated, 100-count bottles,
Rx only. NDC 0008-4130-01.
CODE
A86012, Exp. July 2005.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Richmond Division of Wyeth, Richmond, VA
Manufacturer: Wyeth Pharmaceuticals, Rouses Point, NY.
REASON
Dissolution failure (3 month stability).
VOLUME OF PRODUCT IN COMMERCE
166 bottles.
DISTRIBUTION
Nationwide.
PRODUCT
Glyburide Tablets, USP (micronized) 1.5mg, 100 count bottles, Rx only, NDC 0143-9918-01.
CODE
Lot number: 60831A, Exp. 11/06.
RECALLING FIRM
Recalling Firm: West-Ward Pharmaceutical Corp, Eatontown, NJ
Manufacturer: Hikma Pharmaceuticals, Amman, Jordan.
REASON
Misbranding: tablets debossed with incorrect code (G2 indicated for 3.Omg strength).
VOLUME OF PRODUCT IN COMMERCE
1,308 bottles of 100 tablets.
DISTRIBUTION
Nationwide.
WEEK ENDING MAY 14
PRODUCT
Atenolol Tablets, USP 25 mg, 1000 count bottles, Rx Only.
CODE
Lots 408107D, Exp. 07/2006.
RECALLING FIRM
Able Laboratories, Inc., S. Plainfield, NJ
REASON Subpotent; 6 month stability.
VOLUME OF PRODUCT IN COMMERCE
3,034 packages.
DISTRIBUTION
FL, and OH.
PRODUCT
a) Armour Thyroid (thyroid tablets, USP), 30 mg.,
Rx only, packaged in 100 tablet bottle containers.
Product label contains NDC 0456-0458-01 (FOREST).
b) Armour Thyroid (thyroid tablets, USP), 60 mg.,
Rx only, packaged in 100 tablet bottle containers.
Product label contains NDC 0456-0459-01 (FOREST).
c) Armour Thyroid (thyroid tablets, USP), 120 mg.,
Rx only, packaged in 100 tablet bottle containers.
Product label contains NDC 0456-0461-01 (FOREST).
CODE
a) Lots 034052, 035064, 035066, 036171, and 036456;
b) Lots 034053, 034488, 035065, 035997, 036500, 040423;
c) Lots 034051, 035067, 035995, 035996, 036499, 042018.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Amerisource Health Services, Columbus, OH
Manufacturer: Forest Pharmaceuticals, Inc., Earth City, MO.
REASON Subpotent: Product may not maintain potency throughout shelf life.
VOLUME OF PRODUCT IN COMMERCE
58,544/100 tablet bottles.
DISTRIBUTION
Nationwide.
PRODUCT
Amoxil (trade name), Amoxicillin as Trihydrate, powder for oral suspension,
250 mg/5 mL, 150mL, Rx only, NDC No.: 0029-6009-22.
CODE
Lot T40007, Exp 4/30/2007; Lot No. T40008, Exp 4/30/2007.
RECALLING FIRM
Recalling Firm: GlaxoSmithKline, Inc., Durham, NC
Manufacturer: SmithKline Beecham Corp./dba GlaxoSmithKline, Bristol,
TN.
REASON
Mislabeling: 250mg/5mL bottles may be mislabeled as 250mg/5mL, 100mL bottles.
VOLUME OF PRODUCT IN COMMERCE
201,744 bottles.
DISTRIBUTION
Nationwide.
PRODUCT
a) Forest Armour Thyroid (thyroid tablets, USP), 1û4 Grain (15 mg),
each tablet contains levothyroxine (T4) 9.5 mcg and
liothyronine (T3) 2.25 mcg, packaged in 100-tablet bottles,
RX, NDC 0456-0457-01.
b) Forest Armour Thyroid (thyroid tablets, USP), 1/2 Grain (30 mg),
each tablet contains levothyroxine (T4) 19 mcg and
liothyronine (T3) 4.5 mcg, packaged in 100- and 1,000-tablet
bottles, 10/10-tablet unit dose strips, and in 50,000-tablet
drums for repacking only, RX, NDC 0456-0458-01, -00, -63, and
‚69 respectively.
c) Forest Armour Thyroid (thyroid tablets, USP), 1 Grain (60 mg),
each tablet contains levothyroxine (T4) 38 mcg and
liothyronine (T3) 9 mcg, packaged in 100-, 1,000-, and
5,000-tablet bottles, 10/10-tablet unit dose strips boxes,
and 50,000-tablet drums for repacking only, RX,
NDC 0456-0459-01, -00, -51, -63, and ‚69 respectively.
d) Forest Armour Thyroid (thyroid tablets, USP), 1 1û2 Grain (90 mg),
each tablet contains levothyroxine (T4) 57 mcg and
liothyronine (T3) 13.5 mcg, packaged in 100-tablet bottles,
RX, NDC 0456-0460-01.
e) Forest Armour Thyroid (thyroid tablets, USP), 2 Grain (120 mg),
each tablet contains levothyroxine (T4) 76 mcg and
liothyronine (T3) 18 mcg, packaged in 100- and 1,000-tablet
bottles, 10/10-tablet unit dose strip boxes, and 50,000-tablet
drums for repacking only, RX, NDC 0456-0461-01, -00, -63, and
‚69 respectively.
f) Forest Armour Thyroid (thyroid tablets, USP), 3 Grain (180 mg),
each tablet contains levothyroxine (T4) 114 mcg and
liothyronine (T3) 27 mcg, packaged in 100-tablet bottles,
RX, NDC 0456-0462-01.
g) Forest Armour Thyroid (thyroid tablets, USP), 4 Grain (240 mg),
each tablet contains levothyroxine (T4) 152 mcg and
liothyronine (T3) 36 mcg, packaged in 100-tablet bottles,
RX, NDC 0456-0463-01.
h) Forest Armour Thyroid (thyroid tablets, USP), 5 Grain (300 mg),
each tablet contains levothyroxine (T4) 190 mcg and
liothyronine (T3) 45 mcg, packaged in 100-tablet bottles,
RX, NDC 0456-0464-01.
CODE
a) Lot 080301, Exp. May-05; Lot 080302, Exp. May-05, and
Lot 080303, Exp. May-05;
b) Unit dose ‚ Lot 100317, Exp. Aug-05;
100-tablet bottles ‚ Lot 060325, Exp. May-05,
Lot 080304, Exp. Jun-05; Lot 080329, Exp. Jun-05;
Lot 090317, Exp. Aug-05; Lot 100317, Exp. Aug-05;
50,000-tablet drum ‚ Lot 060324, Exp. May-05;
Lot 080304, Exp. Jun-05; Lot 090317, Exp. Aug-05;
1,000-tablet bottle ‚ Lot 060324, Exp. May-05;
Lot 060325, Exp. May-05; Lot 100317, Exp. Aug-05;
c) Unit dose ‚ Lot 070322, Exp. Jun-05;
100-tablet bottles ‚ Lot 070311, Exp. May-05,
Lot 070321, Exp. Jun-05; Lot 070322, Exp. Jun-05;
1,000-tablet bottles - Lot 090308, Exp. Aug-05;
50,000-tablet drums ‚ Lot 070311, Exp. May-05;
Lot 110319, Exp. Aug-05;
d) 100-tablet bottles ‚ Lot 040355, Exp. Mar-05;
Lot 050315, Exp. Mar-05; Lot 080340, Exp. Jul-05;
Lot 100319, Exp. Aug-05;
e) Unit dose ‚ Lot 080330, Exp. Jul-05;
100-tablet bottles ‚ Lot 040334, Exp. Mar-05,
Lot 040335, Exp. May-05; Lot 070306, Exp. May-05;
Lot 080330, Exp. Jul-05; Lot 100318, Exp. Aug-05;
50,000-tablet drum ‚ Lot 040334, Exp. Mar-05,
Lot 070306, Exp. May-05, Lot 080330, Exp. Jul-05;
1,000-tablet bottles - Lot 040334, Exp. Mar-05;
Lot 040335, Exp. May-05.
f) Lot 050350, Exp. Apr-05; and Lot 080339, Exp. Jul-05;
g) Lot 040347, Exp. Mar-05;
h) Lot 040348, Exp. Mar-05.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Forest Pharmaceuticals, Inc, Earth City, MO
Manufacturer: Forest Pharmaceuticals, Inc, Cincinnati, OH.
REASON
Stability failures.
VOLUME OF PRODUCT IN COMMERCE
6,891/10/10-tab. unit dose strip boxes;
598,552/100-tab. bottles;
10,984/1,000-tab. bottles;
350/5,000-tab. bottles;
441/50,000-tab. drums.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
FLUCONAZOLE TABLETS, 100 mg, 100 count unit dose package, 10 Blister Strips
of 10 tablets, Rx only. NDC 49884-939-74.
CODE
Lot FD971A, expiration date Oct 2006.
RECALLING FIRM/MANUFACTURER Genpharm, Inc., Ontario, Canada
REASON
Misbranding; partially illegible print on blister strips.
VOLUME OF PRODUCT IN COMMERCE
3,600 cartons.
DISTRIBUTION
Nationwide.
PRODUCT
Prascion (sodium sulfacetamide 10% and sulfur 5%) Cleanser, Rx only, 6 oz (170.3
g).
CODE
Lot #GB472, GB500 & GB803.
RECALLING FIRM
Kiel Laboratories, Inc., Gainesville, GA
REASON Subpotent: The product may become sub-potent prior to reaching the assigned
24 month expiration date.
VOLUME OF PRODUCT IN COMMERCE
11,647 units.
DISTRIBUTION
Nationwide.
PRODUCT
a) Armour Thyroid (thyroid tablets, USP), 1/2 Grain (30 mg),
each tablet contains levothyroxine (T4) 19 mcg and
liothyronine (T3) 4.5 mcg, packaged in 100-tablet
bottles, Rx, NDC 0456-0458-01.
b) Armour Thyroid (thyroid tablets, USP), 1 Grain (60 mg),
each tablet contains levothyroxine (T4) 38 mcg and
liothyronine (T3) 9 mcg, packaged in 100-tablet bottles,
Rx, NDC 0456-0459-01.
CODE
a) Lot Nos.: 09164, 09330, 09792, 10427, 10918, 11215;
b) Lot Nos.: 09530, 09531, 09787, 10011,10794, 11540, 11541.
RECALLING FIRM
Rx PAK, Memphis, TN
REASON
Stability Failure.
VOLUME OF PRODUCT IN COMMERCE
135,500 units.
DISTRIBUTION
Nationwide.
WEEK ENDING MAY 21
PRODUCT
Neurontin Capsules (Gabapentin), 100 mg 100 count bottles, Rx only, NDC 0071-0803-24.
CODE
Lot 15224V, Expiration 08/2007.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer, Inc., NY, NY
REASON Subpotent; some capsules may be empty or partially filled.
VOLUME OF PRODUCT IN COMMERCE
40,101.
DISTRIBUTION
Nationwide.
PRODUCT
Adderall XR (Mixed Salts of a Single Entity Amphetamine Product) Extended Release
Capsules 20mg 100 Capsules, Rx only. Each capsule contains: Dextroamphetamine
Sacccharate 5.0mg, Dextroamphetamine Sulfate USP 5.0mg: Amphetamine Sulfate
USP 5.0mg, total amphetamine base equivalence 12.5mg.
CODE
Lot # A00819A.
RECALLING FIRM
Recalling Firm: Shire Us Inc., Newport, KY
Manufacturer: DSM Pharmaceuticals, Inc., Greenville, NC.
REASON
Mislabeling: Adderall XR 30 mg capsules were found within one bottle labeled
Adderall XR 20 mg capsules.
VOLUME OF PRODUCT IN COMMERCE
10,919 bottles (100 capsules per bottle).
DISTRIBUTION
Nationwide.
PRODUCT
Fluorescite 10% Injection, 100mg/ml fluorescein, 5 mL Sterile, Rx only.
CODE
Lot numbers: Z13048, Z13051, Z13052, Z13123, and Z13124.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alcon Research, Ltd, Fort Worth, TX
Manufacturer: Cardinal Health Manufacturing Services B.V., Humacao, PR.
REASON
Lack of Assurance of Sterility.
VOLUME OF PRODUCT IN COMMERCE
Approximately 5,000 units.
DISTRIBUTION
Japan, Canada, Germany, Austria, and Korea.
PRODUCT
Cortisporin Ophthalmic Suspension, Sterile, (neomycin and polymyxin B. sulfates
and hydrocortisone ophthalmic suspension, USP, Each mL contains neomycin sulfate
equivalent to 3.5mg neomycin base, polymyxin B sulfate equivalent to 10,000
polymyxin B units, hydrocortisone 10 mg (1%), 7.5mL bottle, Rx only, NDC 61570-036-75.
CODE
Lot numbers: 211802, Exp. 07/05 and A04162, Exp. 06/06.
RECALLING FIRM/MANUFACTURER
Recalling Firm: King Pharmaceuticals, Inc., Bristol, TN
Manufacturer: DSM Pharmaceuticals, Inc., Greenville, NC.
REASON
Subpoten (hydrocortisone, 6 month stability).
VOLUME OF PRODUCT IN COMMERCE
36,475 bottles.
DISTRIBUTION
Nationwide.
PRODUCT
Intravenous Sodium Edecrin (Ethacrynate Sodium) 50 mg single use vial, Rx only.
NDC 0006-3620-50.
CODE
Lot # 1045P Exp. 2/28/06 and Lot # 0127R Exp. 3/31/06.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Merck & Co, Inc., Merck Manufacture, West Point, PA
Manufacturer: Ben Venue Laboratories, Inc., Bedford, OH.
REASON Subpotent.
VOLUME OF PRODUCT IN COMMERCE
6,983 vials.
DISTRIBUTION
Nationwide.
PRODUCT
Cardiolite Kit for the Preparation of Technetium Tc99m Sestamibi for Injection.
CODE
Lot number: 3847M Exp. October 1, 2006.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bristol-Myers Squibb Medical Imaging, Inc., North Billerica,
MA
Manufacturer: Bristol Myers Squibb Holdings Pharma., Ltd., Manati, PR.
REASON
Lack of assurance of sterility (Vial seal integrity).
VOLUME OF PRODUCT IN COMMERCE
18,495 vials.
DISTRIBUTION
Nationwide.
PRODUCT
Premarin (conjugated estrogen tablets, USP), 0.3 mg, packaged in 100 tablet
size bottles, containing NDC 0046-0868-81 (AYERST).
CODE
Lot 030793, Exp. July 31, 2005.
RECALLING FIRM
Recalling Firm: Amerisource Health Services, Columbus, OH
Manufacturer: Wyeth Pharmaceuticals, Rouses Point, NY.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
5,395/100 tablet bottles.
DISTRIBUTION
Nationwide.
PRODUCT
Tylenol Acetaminophen Extended Release Arthritis Pain, for the temporary relief
of minor arthritis pain. Retail carton dispenser: Acetaminophen 250 mg, Retail
individual pouch: Acetaminophen 650 mg.
CODE
Lot Number JCM044.
RECALLING FIRM/MANUFACTURER
Select Distributors, Inc, Dallas, TX
REASON
Mislabeling: Retail dispensing carton indicates wrong strength of Acetaminophen
but retail pouches are labeled with proper strength.
VOLUME OF PRODUCT IN COMMERCE
1,250 Cartons containing 50 pouches.
DISTRIBUTION
Nationwide.
WEEK ENDING MAY 28
PRODUCT
Actra-Rx Gentlemen Nutritional Supplement Capsules, Proprietary Blend: Amino
acid blend (Proline, Histidine, Glutamic Acid, Argenine, Aspartic Acid, Tyrosine,
Phenylalanine, Lysine, Leucine, Glycosine, Threonine, iso-Leucine, Alanine,
Senine, Methionine, Trytophane and Cystis Acid) Lycium (Fruit), Epimedium (Herb)
Cistanche (Root) Vitamins B1, B2 and Minerals, 450mg, 5 count bottles, No Preservatives
Added.
CODE
Lot 001-3, Exp date December 2005.
RECALLING FIRM
Recalling Firm: Body Basics Inc,. Canoga Park, CA,
Manufacturer: Shenyang Chang Gang Yibao Alcohol Co., Ltd,
Shenyang, Liaoning, Mainland China.
REASON
Unapproved New Drug; contains undeclared sildenafil citrate.
VOLUME OF PRODUCT IN COMMERCE
15,000 tablets.
DISTRIBUTION
Nationwide.
PRODUCT
Butorphanol Tartrate Nasal Spray, 10 mg/mL, 2.5 mL bottle with Metered-dose
Spray Pump, packaged in boxes of 48 bottles, Rx only, **** NDC 0378-9639-43.
CODE
LAL041 Exp 6/05 LAL042 Exp 7/05 LAL045 Exp 11/05.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mylan Pharmaceuticals Inc., Morgantown, WV
Manufactured by Patheon, Inc. Mississauga, Ontario, Canada.
REASON
Short fill; could result in higher concentration of active ingredient.
VOLUME OF PRODUCT IN COMMERCE
91,570 bottles.
DISTRIBUTION
Nationwide.
PRODUCT
Famotidine Injection, 20mg/2mL*, Each mL contains 10 mg of famotidine, 10 Bags
of One 2mL Single Dose Vial Each, For the Preparation of IV Solutions, ****
NDC # 55390-029-10.
CODE
Lot 045715, exp. 04/06.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Amerisource Health Services, Columbus, OH
Manufacturer: Ben Venue Labs, Inc., Bedford, OH.
REASON
Lack of sterility assurance (by manufacturer).
VOLUME OF PRODUCT IN COMMERCE
180 boxes/10 vials per box.
DISTRIBUTION
GA.
PRODUCT
Haloperidol Oral Solution USP, (Concentrate), 2mg/mL, * NDC 0121-0581-04, NSN
6505-01-003-5341 * For Dropper Dosage Only, Each mL contains: 2mg Haloperidol
(as the lactate0 * Rx Only * 4 fl oz (120mL).
CODE
Lot 4K55 and 4L72.
RECALLING FIRM
Pharmaceutical Associates, Inc., Greenville, SC
REASON
Labeling: When the screw cap dropper assembly is placed into the product the
integrity of the ink used to identify the dosage levels may be compromised over
time. As a result, the dosage markings may either be difficult or impossible
to read.
VOLUME OF PRODUCT IN COMMERCE
17,367 bottles.
DISTRIBUTION
Nationwide.
PRODUCT
Biore PORE PERFECT Warming Anti-Blackhead Cream Cleanser Heats & Treats******Salicylic
Acid OTC Acne Treatment Oil-Free, 6.25 oz (177g), Stock #03017, packed in shipping
cases containing 12 x 6.25 oz tubes per case. The outer cartons and some tubes
inside the shipping cartons are labeled as listed above, and all of the tubes
contain the above referenced product; however, some tubes containing anti-blackhead
cream cleanser are labeled as follows: Biore PORE PERFECT Pore Unclogging Scrub
exfoliates & refines****** Salicylic Acid Acne Treatment, Oil-Free 5 oz
(141 g).
CODE
Lot Numbers: T034CB02, T035CB02,04 & T035CB03.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kao Brands Company, Cincinnati, OH
Manufacturer: Medicia Corp., Dayton, NJ.
REASON Mispackaging: Shipping cartons distributed, which were labeled as containing
one OTC product [Anti-blackhead Cleanser] but cartons contain retail tubes of
product labeled as containing another OTC product [Pore Unclogging Scrub].
VOLUME OF PRODUCT IN COMMERCE
51,648 tubes.
DISTRIBUTION
Nationwide.
PRODUCT PEG-Intron Redipen (Peginterferon alfa-2b), 80mcg/.5mL, For Subcutaneous Use,
Rx only, NDC 0085-1316-01.
CODE
Lot 3-IRG-303 exp. May 2006.
RECALLING FIRM
Schering Plough Corp, Kenilworth, NJ
REASON
Labeling: Needles in the kit have an expiration date that is earlier than the
expiration date of the PEG-Intron Redipen itself.
VOLUME OF PRODUCT IN COMMERCE
23,226 units.
DISTRIBUTION
Nationwide.
FDA Advises Consumers about Recalled Drugs from Able Laboratories
The Food and Drug Administration (FDA) is taking action to ensure that the public is fully aware that Able Laboratories of Cranbury, NJ, is conducting a nationwide recall of all of its manufactured drugs (mostly generic prescription drugs, including drugs containing acetaminophen) because of serious concerns that they were not produced according to quality assurance standards. Able Laboratories has ceased all current production.
"The FDA continues to evaluate the situation at Able Laboratories to determine the safety and quality of their products and will update the public on our findings as necessary," said Margaret O'K. Glavin, Associate Commissioner for Regulatory Affairs. "In the meantime, the Agency recommends that people who have been taking drugs produced by this firm speak with their health care provider or pharmacist to obtain a replacement drug product. Consumers should continue taking the medication until they have spoken with their health care provider. In many cases the risk of suddenly stopping needed medication before getting replacement drugs may outweigh the risk of continuing to use the recalled products."
The list below provides the names of the recalled drugs and their imprint codes. Imprints are marks (usually letters and numbers) found on the surfaces of drugs. If you have one of the drugs listed below with one of the corresponding imprint codes, your drug is covered by the Able Laboratories recall.
Liquid products that are being recalled can be identified by the lot numbers printed on their packaging.
It is important to note that this recall only applies to the drugs produced by Able Laboratories -- and not to the same drugs produced by other manufacturers.
| GENERIC NAME |
SIZE |
Imprint Side 1 |
Imprint side 2 |
|---|---|---|---|
| ACETAMINOPHEN & CODEINE 300MG -30MG TAB |
100 |
A285 |
3 |
| ACETAMINOPHEN & CODEINE 300MG -30MG TAB |
500 |
A285 |
3 |
| ACETAMINOPHEN & CODEINE 300MG -30MG TAB |
1000 |
A285 |
3 |
| ACETAMINOPHEN & CODEINE 300MG -60MG TAB |
100 |
A286 |
4 |
| ACETAMINOPHEN & CODEINE 300MG -60MG TAB |
500 |
A286 |
4 |
| ACETAMINOPHEN & CODEINE 300MG -60MG TAB |
1000 |
A286 |
4 |
| ATENOLOL TABLETS 25 MG TAB |
100 |
A412 |
|
| ATENOLOL TABLETS 25 MG TAB |
1000 |
A412 |
|
| ATENOLOL TABLETS 50 MG TAB |
100 |
A413 |
|
| ATENOLOL TABLETS 50 MG TAB |
1000 |
A413 |
|
| ATENOLOL TABLETS 100 MG TAB |
100 |
A414 |
|
| ATENOLOL TABLETS 100 MG TAB |
1000 |
A414 |
|
| BETHANECHOL CHLORIDE TABS 5 MG TAB |
100 |
A339 |
|
| BETHANECHOL CHLORIDE TABS 10 MG TAB |
100 |
A340 |
|
| BETHANECHOL CHLORIDE TABS 25 MG TAB |
100 |
A338 |
|
| BETHANECHOL CHLORIDE TABS 50 MG TAB |
100 |
A341 |
|
| BUTALBITAL/APAP/CAFFEINE 50-325-40 MG TAB |
100 |
A236 |
|
| BUTALBITAL/APAP/CAFFEINE 50-325-40 MG TAB |
500 |
A236 |
|
| BUTALBITAL/APAP/CAFFEINE 50-500-40 MG TAB |
100 |
A235 |
|
| BUTALBITAL/APAP/CAFFEINE 50-500-40 MG TAB |
500 |
A235 |
|
| BUTALBITAL/APAP/CAFF/CODEINE 50/325/40/30 CAP |
100 |
A |
240 |
| CARISOPRODOL 350 MG TAB |
100 |
A266 |
|
| CARISOPRODOL 350 MG TAB |
500 |
A266 |
|
| CARISOPRODOL 350 MG TAB |
1000 |
A266 |
|
| CLORAZEPATE DIPOTASSIUM 3.75 MG TAB |
100 |
AL |
|
| CLORAZEPATE DIPOTASSIUM 3.75 MG TAB |
500 |
AL |
|
| CLORAZEPATE DIPOTASSIUM 7.5 MG TAB |
100 |
AM |
|
| CLORAZEPATE DIPOTASSIUM 7.5 MG TAB |
500 |
AM |
|
| CLORAZEPATE DIPOTASSIUM 15 MG TAB |
100 |
AN |
|
| DIPHENOXYLATE/ATROPINE 2.5-0.025 MG TAB |
100 |
A |
237 |
| DIPHENOXYLATE/ATROPINE 2.5-0.025 MG TAB |
1000 |
A |
237 |
| HYDROCODONE BITARTRATE APAP 5-325 MG TAB |
100 |
A345 |
|
| HYDROCODONE BITARTRATE APAP 5-325 MG TAB |
500 |
A345 |
|
| HYDROCODONE BITARTRATE APAP 5-500 MG TAB |
100 |
A329 |
|
| HYDROCODONE BITARTRATE APAP 5-500 MG TAB |
500 |
A329 |
|
| HYDROCODONE BITARTRATE APAP 7.5-325 MG TAB |
100 |
A335 |
|
| HYDROCODONE BITARTRATE APAP 7.5-325 MG TAB |
500 |
A335 |
|
| HYDROCODONE BITARTRATE APAP 7.5-500 MG TAB |
100 |
A330 |
|
| HYDROCODONE BITARTRATE APAP 7.5-500 MG TAB |
500 |
A330 |
|
| HYDROCODONE BITARTRATE APAP 7.5-650 MG TAB |
100 |
A332 |
|
| HYDROCODONE BITARTRATE APAP 7.5-650 MG TAB |
500 |
A332 |
|
| HYDROCODONE BITARTRATE APAP 7.5-750 MG TAB |
100 |
A334 |
|
| HYDROCODONE BITARTRATE APAP 7.5-750 MG TAB |
500 |
A334 |
|
| HYDROCODONE BITARTRATE APAP 10-325 MG TAB |
100 |
A328 |
|
| HYDROCODONE BITARTRATE APAP 10-325 MG TAB |
500 |
A328 |
|
| HYDROCODONE BITARTRATE APAP 10-500 MG TAB |
100 |
A331 |
|
| HYDROCODONE BITARTRATE APAP 10-500 MG TAB |
500 |
A331 |
|
| HYDROCODONE BITARTRATE APAP 10-650 MG TAB |
100 |
A333 |
|
| HYDROCODONE BITARTRATE APAP 10-650 MG TAB |
500 |
A333 |
|
| HYDROCORTISONE ACETATE 25 MG SUPP |
12 |
AL0761F/02(foil) |
|
| HYDROCORTISONE ACETATE 25 MG SUPP |
24 |
AL0761F/02(foil) |
|
| HYDROXYZINE HCL 10 MG TAB |
100 |
A |
387 |
| HYDROXYZINE HCL 10 MG TAB |
500 |
A |
387 |
| HYDROXYZINE HCL 10 MG TAB |
1000 |
A |
387 |
| HYDROXYZINE HCL 25 MG TAB |
100 |
A |
388 |
| HYDROXYZINE HCL 25MG TAB |
500 |
A |
388 |
| HYDROXYZINE HCL 25 MG TAB |
1000 |
A |
388 |
| HYDROXYZINE HCL 50 MG TAB |
100 |
A |
389 |
| HYDROXYZINE HCL 50 MG TAB |
500 |
A |
389 |
| HYDROXYZINE HCL 50 MG TAB |
1000 |
A |
389 |
| INDOMETHACIN 25 MG CAP |
100 |
267 |
A |
| INDOMETHACIN 25 MG CAP |
1000 |
267 |
A |
| INDOMETHACIN 50 MG CAP |
100 |
268 |
A |
| INDOMETHACIN 50 MG CAP |
500 |
268 |
A |
| INDOMETHACIN ER 75 MG CAP |
60 |
A |
269 |
| INDOMETHACIN ER 75 MG CAP |
100 |
A |
269 |
| LITHIUM CARBONATE 150 MG CAP |
100 |
A |
355 |
| LITHIUM CARBONATE 150 MG CAP |
500 |
A |
355 |
| LITHIUM CARBONATE 300 MG CAP |
100 |
A |
270 |
| LITHIUM CARBONATE 300 MG CAP |
1000 |
A |
270 |
| LITHIUM CARBONATE ER 300 MG TAB |
100 |
A283 |
|
| LITHIUM CARBONATE 600 MG CAP |
100 |
A |
356 |
| METHAMPHETAMINE 5 MG TAB CII |
100 |
A396 |
|
| METHOCARBAMOL 500 MG TAB |
100 |
A265 |
|
| METHOCARBAMOL 500 MG TAB |
500 |
A265 |
|
| METHOCARBAMOL 750 MG TAB |
100 |
A264 |
|
| METHOCARBAMOL 750 MG TAB |
500 |
A264 |
|
| METHYLPHENIDATE HCl 5 MG TAB CII |
100 |
A |
253 |
| METHYLPHENIDATE HCl 5 MG TAB CII |
1000 |
A |
253 |
| METHYLPHENIDATE HCl 10 MG TAB CII |
100 |
A |
254 |
| METHYLPHENIDATE HCl 10 MG TAB CII |
1000 |
A |
254 |
| METHYLPHENIDATE HCl 20 MG TAB CII |
100 |
A |
255 |
| METHYLPHENIDATE HCl 20 MG TAB CII |
1000 |
A |
255 |
| METHYLPHENIDATE HCl ER 20 MG TAB CII |
100 |
A262 |
|
| METHYLPHENIDATE HCl ER 20 MG TAB CII |
1000 |
A262 |
|
| METRONIDAZOLE 250 MG TAB |
100 |
A374 |
|
| METRONIDAZOLE 250 MG TAB |
250 |
A374 |
|
| METRONIDAZOLE 250 MG TAB |
500 |
A374 |
|
| METRONIDAZOLE 500 MG TAB |
60 |
A375 |
|
| METRONIDAZOLE 500 MG TAB |
100 |
A375 |
|
| METRONIDAZOLE 500 MG TAB |
500 |
A375 |
|
| METRONIDAZOLE ER 750 MG TAB |
30 |
A352 |
|
| METRONIDAZOLE 375 MG CAP |
50 |
A |
353 |
| NAPROXEN SODIUM 275 MG TAB |
100 |
A363 |
|
| NAPROXEN SODIUM 275 MG TAB |
500 |
A363 |
|
| NAPROXEN SODIUM 550 MG TAB |
100 |
A364 |
|
| NAPROXEN SODIUM 550 MG TAB |
500 |
A364 |
|
| NITROGLYCERIN SUBLINGUAL 0.3 MG SL TAB |
100 |
1 |
|
| NITROGLYCERIN SUBLINGUAL 0.4 MG SL TAB |
100 |
2 |
|
| NITROGLYCERIN SUBLINGUAL 0.4 MG SL TAB |
4X25 |
2 |
|
| NITROGLYCERIN SUBLINGUAL 0.6 MG SL TAB |
100 |
3 |
|
| PHENAZOPYRIDINE HCl 100 MG TAB |
100 |
AP1 |
|
| PHENAZOPYRIDINE HCl 100 MG TAB |
1000 |
AP1 |
|
| PHENAZOPYRIDINE HCl 200 MG TAB |
100 |
AP2 |
|
| PHENAZOPYRIDINE HCl 200 MG TAB |
1000 |
AP2 |
|
| PHENTERMINE POWDER 15 MG CAP |
100 |
A |
346 |
| PHENTERMINE POWDER 15 MG CAP |
1000 |
A |
346 |
| PHENTERMINE BEADS 30 MG CAP |
100 |
A |
259 |
| PHENTERMINE BEADS 30 MG CAP |
1000 |
A |
259 |
| PHENTERMINE POWDER 30 MG CAP |
100 |
A |
258 |
| PHENTERMINE POWDER 30 MG CAP |
1000 |
A |
258 |
| PHENTERMINE 37.5 MG TAB |
100 |
A257 |
|
| PHENTERMINE 37.5 MG TAB |
1000 |
A257 |
|
| PROCHLORPERAZINE 2.5 MG SUPP |
12 |
AL0762F |
|
| PROCHLORPERAZINE 5 MG SUPP |
12 |
AL0763F |
|
| PROCHLORPERAZINE 25 MG SUPP |
12 |
AL0746F |
|
| PROMETHAZINE 12.5MG SUPP |
12 |
AL0765/01 |
|
| PROMETHAZINE 25 MG SUPP |
12 |
AL0766F/01 |
|
| PROMETHAZINE 50 MG SUPP |
12 |
AL0767F/01 |
|
| PROMETHAZINE TABLETS 12.5 MG TAB |
100 |
A405 |
|
| PROMETHAZINE TABLETS 25 MG TAB |
100 |
A406 |
|
| PROMETHAZINE TABLETS 25 MG TAB |
1000 |
A406 |
|
| PROMETHAZINE TABLETS 50 MG TAB |
100 |
A407 |
|
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
100 |
A256 |
|
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
500 |
A256 |
|
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
1000 |
A256 |
|
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
100 |
A261 |
|
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
500 |
A261 |
|
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
1000 |
A261 |
|
| SALSALATE 500 MG TAB |
100 |
A500 |
|
| SALSALATE 500 MG TAB |
500 |
A500 |
|
| SALSALATE 750 MG TAB |
100 |
A750 |
|
| SALSALATE 750 MG TAB |
500 |
A750 |
|
| THEOPHYLLINE ER 400 MG TAB |
100 |
A380 |
|
| THEOPHYLLINE ER 400 MG TAB |
500 |
A380 |
|
| THEOPHYLLINE ER 600 MG TAB |
100 |
A382 |
|
| Ivax Label -Private Label Manufactured by Able Labs |
Imprint |
Lot # |
Lot # |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306060A |
402154A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306061A |
402155A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306062A |
402156A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306063A |
402157A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306063A |
402158A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306064A |
402158A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306065A |
402159A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306066A |
402166A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306067A |
402167A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306068A |
402168A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306068A |
402169A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306069A |
402170A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306070A |
403001A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306071A |
403002A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306072A |
403003A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306073A |
403004A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306074A |
403005A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307011A |
403006A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307012A |
403007A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307013A |
403008A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307014A |
403009A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307015A |
403010A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307016A |
403099A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307017A |
403100A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307018A |
403101A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307019A |
403102A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307019A |
403103A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307020A |
403104A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307126A |
403105A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307127A |
403106A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307128A |
403107A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307129A |
403107A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307130A |
403108A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307131A |
403108A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307132A |
403157A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307133A |
403157A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307134A |
403157A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307135A |
403158A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307296A |
403158A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307297A |
403159A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307298A |
403160A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307299A |
403161A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
309013A |
403164A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
309014A |
403165A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
309015A |
403166A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
309016A |
403167A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
309017A |
403168A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
309018A |
404046A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
309019A |
404047A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
310113A |
404047A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
310114A |
404048A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
310115A |
404049A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
310116A |
404050A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
310117A |
404087A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312011A |
404088A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312011A |
404089A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312012A |
404090A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312013A |
404091A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312013A |
404105A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312014A |
404106A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312014A |
404107A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312015A |
404108B |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312015A |
404108B |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312021A |
404109A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312022A |
404109A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312023A |
406116A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312024A |
406116A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312024A |
406117A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312025A |
406117A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312141A |
406118A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312142A |
406118A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312143A |
406119A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312144A |
406119A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312144A |
406120A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312145A |
406121A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
401077A |
406122A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
401078A |
406123A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
401079A |
406124A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
401080A |
406125A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
401081A |
410059A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
402047A |
410060A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
402048A |
410061A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
402049A |
410062A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
402050A |
410063A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
402051A |
410064A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
402069A |
410065A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
402069A |
410065A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
402070A |
410066A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
402071A |
410067A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
402072A |
410068A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
402073A |
411030A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
402150A |
411031A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
402151A |
411032A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
402152A |
411033A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
402153A |
411034A |
| Tramadol HCL Tabs 50mg 10x10's (blister) Ivax |
402165A |
||
| Tramadol HCL Tabs 50mg 10x10's (blister) Ivax |
410132A |
||
| Tramadol HCL Tabs 50mg 10x10's (blister) Ivax |
411118B |
||
| TRAMADOL HCL 50MG TABS |
A273 |
401174A |
405046A |
| TRAMADOL HCL 50MG TABS |
A273 |
401175A |
405047A |
| TRAMADOL HCL 50MG TABS |
A273 |
401176A |
405048A |
| TRAMADOL HCL 50MG TABS |
A273 |
401177A |
405049A |
| TRAMADOL HCL 50MG TABS |
A273 |
401178A |
405050A |
| TRAMADOL HCL 50MG TABS |
A273 |
402161A |
405075A |
| TRAMADOL HCL 50MG TABS |
A273 |
402162A |
405076A |
| TRAMADOL HCL 50MG TABS |
A273 |
402163A |
405077A |
| TRAMADOL HCL 50MG TABS |
A273 |
402164A |
405078A |
| TRAMADOL HCL 50MG TABS |
A273 |
405070A |
410182A |
| TRAMADOL HCL 50MG TABS |
A273 |
405071A |
411115A |
| TRAMADOL HCL 50MG TABS |
A273 |
405072A |
411116A |
| TRAMADOL HCL 50MG TABS |
A273 |
405073A |
411117A |
| TRAMADOL HCL 50MG TABS |
A273 |
405074B |
411119A |
| TRAMADOL HCL 50MG TABS |
A273 |
405079A |
412092A |
| TRAMADOL HCL 50MG TABS |
A273 |
406001A |
412093A |
| TRAMADOL HCL 50MG TABS |
A273 |
406002A |
412094A |
| TRAMADOL HCL 50MG TABS |
A273 |
406003A |
412095A |
| TRAMADOL HCL 50MG TABS |
A273 |
408208A |
412096A |
| TRAMADOL HCL 50MG TABS |
A273 |
408209A |
412096A |
| TRAMADOL HCL 50MG TABS |
A273 |
410133A |
502111A |
| TRAMADOL HCL 50MG TABS |
A273 |
410134A |
502112A |
| TRAMADOL HCL 50MG TABS |
A273 |
410135A |
410136A |
| TRAMADOL HCL 50MG TABS |
A273 |
410179A |
410137A |
| TRAMADOL HCL 50MG TABS |
A273 |
410181A |
410138A |
| TRAMADOL HCL 50MG TABS |
A273 |
410178A |
410180A |
| Major Label - Private Label Manufactured by Able Labs |
Imprint |
Lot # |
Lot # |
| LITHIUM CARBONATE CAP 300mg |
A270 |
307172A |
|
| LITHIUM CARBONATE CAP USP |
A270 |
307172A |
|
| LITHIUM CARBONATE CAP 300mg |
A270 |
310089A |
|
| PROPOXYPHENE NAPSYLATE/ APAP |
A256 |
307266A |
|
| Hawthorn Label - Private Label Manufactured by Able Labs |
Imprint |
Lot # |
Lot # |
| Dytan- Suspension |
L409001A |
||
| Dytan- Suspension |
L409002A |
||
| Dytan-D Suspension |
L412001A |
||
| Dytan-D Suspension |
L401007 |
||
| Dytan-D Suspension |
L401008 |
||
| Dytan-D Suspension |
L401009 |
||
| Dytan-D Suspension |
L401009 |
||
| Dytan-D Suspension |
L401010 |
||
| Dytan-D Suspension |
L401010 |
||
| Dytan-D Suspension |
L403002 |
||
| Dytan-D Suspension |
L404002 |
||
| Dytan-D Suspension |
L404002 |
||
| Dytan-D Suspension |
L404003 |
||
| Dytan-D Suspension |
L404003 |
||
| Dytan-D Suspension |
L404004 |
||
| Dytan-D Suspension |
L404004 |
||
| Dytan-D Suspension |
L404005 |
||
| Dytan-D Suspension |
L404005 |
||
| Cypress Label - Private Label Manufactured by Able Labs |
Imprint |
Lot # |
Lot # |
| Liqui- Stride Concentrate |
L402003 |
||
| Liqui- Stride Concentrate |
L402004 |
||
| Andehist-NR Syrup |
3L04 |
||
| Andehist-NR Syrup |
3L04 |
||
| Andehist-NR Syrup |
3L05 |
||
| Andehist-NR Syrup |
L401002 |
||
| Andehist-NR Oral Drop |
3L07 |
||
| Andehist-NR Oral Drop |
3L08 |
||
| Andehist-NR Oral Drop |
3L08 |
||
| Andehist-NR Oral Drop |
3L02 |
||
| Andehist-NR Oral Drop |
3L02 |
||
| Andehist-NR Oral Drop |
3L03 |
||
| Andehist-NR Oral Drop |
L401001 |
||
| Bromhist-DM Drops |
3L06 |
||
| Bromhist-DM Drops |
3L06 |
||
| Breckenridge Label - Private Label Manufactured by Able Labs |
Imprint |
Lot # |
Lot # |
| Quad Tann Pediatric Suspension |
3L01 |
It is important to note that this recall only applies to the drugs produced by Able Laboratories – and not to the same drugs produced by other manufacturers. An investigation is underway to identify all the repackers and wholesalers who distribute these drugs from Able Laboratories. In the meantime, the best way for consumers to know whether they have a product produced by Able Laboratories is to check the list below and either contact their pharmacist or compare the imprint numbers on their individual tablets with the imprint numbers listed on the FDA website.
Consumers with questions may contact Able Laboratories at 1-800-982-2253. Persons wanting to report any adverse events to the FDA may contact FDA’s MedWatch office at 1-800-FDA-1088.