AUGUST 2004Skip Navigation

 

WEEK ENDING AUGUST 7

 

PRODUCT Twice-a-Day 12 HOUR NASAL SPRAY (oxymetazoline hydrocholoride 0.05%), sold in 1/2 FL. OZ (14.8mL) and 1 FL. OZ. (30mL) bottles, MAJOR brand, Regular, NASAL DECONGESTANT, NDC 0904-5217-35, Also sold under other name brand as: DU brand Nasal Spray Atomizador, Maximum Strength, Nasal Decongestant Spray.
CODE Lots sold under MAJOR brand: K4496, A4588, L4535, E4410, F4433, H4464, L4529, M4536, A4558 and B459. Lot sold under DU brand: J4492.
RECALLING FIRM/MANUFACTURER Propharma, Inc., Miami, FL.
REASON Microbial contamination; Burkholderia cepacia.
VOLUME OF PRODUCT IN COMMERCE 416,677 bottles.
DISTRIBUTION Nationwide.


PRODUCT Children's Motrin Tablets (ibuprofen) 50 mg, 24 count bottles, Grape-Flavored Chewable Tablets, Pain Reliever/Fever Reducer, NDC 50580-907-24.
CODE JAM108, Expiration Date 01/2006.
RECALLING FIRM/MANUFACTURER McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil-PPC, Inc., Fort Washington, PA.
REASON Mislabeled; bottles labeled as Children's Motrin Chewable Tablets actually contain Tylenol 8 Hour Geltabs.
VOLUME OF PRODUCT IN COMMERCE 73,248 bottles with 24 tablets.
DISTRIBUTION Nationwide.


PRODUCT 5% Lidocaine HCI and 7.5% Dextrose Injection, USP, 2mL ampul ‚ 5 single ampuls, Single-dose Container, NDC 0074-4712-01.
CODE Lot 09-568-DK, Expiration Date: Sept. 1, 2006.
RECALLING FIRM/MANUFACTURER Hospira Inc., Rocky Mount, NC.
REASON Some ampuls were found to contain particulates.
VOLUME OF PRODUCT IN COMMERCE 139,600 units.
DISTRIBUTION Nationwide.


PRODUCT Trispec-PE Pediatric Drops, Each teaspoonful (5 ml) contains: Dextromethorphan HBr 10 mg, Pseudoephedrine HCI 30 mg, and Guaifenesin 25 mg, 1 Fl oz. bottles, Grape Flavor, Sugar Free, Dye Free,--- NDC 58238-210-01.
CODE Lot # 2K143, Exp. Date 10/04.
RECALLING FIRM/MANUFACTURER Deliz Pharmaceutical Corp., Carolina, PR.
REASON Superpotent; (18 month stability).
VOLUME OF PRODUCT IN COMMERCE 11,450.
DISTRIBUTION Puerto Rico.

 

PRODUCT Nu-IronÆ V, Polysaccharide-Iron Complex, Each Maroon Film-Coated Tablet contains: Iron (Elemental) 60mg (as a Polysaccharide-Iron Complex); Folic Acid 1mg; Ascorbic Acid 50mg (as sodium ascorbate); Cyanocobalamin (Vitamin B12) 3mcg; Vitamin A 4,000 I.U.; Vitamin D2 400 I.U.; Thiamine Mononitrate 3mg; Riboflavin 3mg; Pyridoxine Hydrochloride 2mg Niacinamide 10mg; Calcium Carbonate 312mg), 10 x 10 count blister packs (PVC/Foil), Rx only, NDC 0259-0331-01.
CODE Lot R0401, Expiration Date 06-05.
RECALLING FIRM/MANUFACTURER Merz Pharmaceuticals, Greensboro, NC.
REASON Sub-potent (Calcium Carbonate).
VOLUME OF PRODUCT IN COMMERCE 1,187 boxes.
DISTRIBUTION Nationwide.


PRODUCT Calcitriol Injection, 1 mcg/mL, 1 mL Single Dose Ampul, 10 ampuls per tray, 5 trays per carton, Rx only, Sterile, For IV Use, NDC 63323-731-01. 
CODE Lot 2G1492, exp. 11/2004.
RECALLING FIRM/MANUFACTURER American Pharmaceutical Partners, Inc., Melrose Park, IL.
REASON Discoloration; Failed Visual and Instrumental Color Specification.
VOLUME OF PRODUCT IN COMMERCE 39,800 units.
DISTRIBUTION Nationwide.


PRODUCT Premarin (conjugated estrogens tablets, USP), 0.625 mg, 100 and 1000 count bottles, Rx only, NDC 0046-0867-81.
CODE
100 count, Lot 04597, Exp 09/04;
1000 count, Lot 04606, Exp 09/04.
RECALLING FIRM/MANUFACTURER Rx PAK, Memphis, TN.
REASON Product failed to meet dissolution specifications.
VOLUME OF PRODUCT IN COMMERCE 40,679 bottles of 100 and 1775 bottles of 1000.
DISTRIBUTION Nationwide.

 

Skip NavigationWEEK ENDING AUGUST 21


PRODUCT DSM Lidocaine, USP, BP, & Ph. Eur, Acetamide, 2-(diethylamino)-N-(2,6-dimethylpheny), net wt. 25.00 KG.
CODE Lot LA-03E18-C.
RECALLING FIRM/MANUFACTURER DSM Pharma Chemicals South Haven, Inc., South Haven, MI.
REASON Presence of foreign particles: Failed USP chloride limit test.
VOLUME OF PRODUCT IN COMMERCE 75 kg.
DISTRIBUTION MI, and Japan.

 

Skip NavigationWEEK ENDING AUGUST 28


PRODUCT
a) Levoxyl Tablets, (Levothyroxine Sodium Tablets) USP, 50mcg, 100 tablet bottles, Rx only.

NDC 5260-4505-01;
b) Levoxyl Tablets, (Levothyroxine Sodium Tablets) USP, 100mcg, 100 tablet bottles, Rx only.

NDC 5260-4510-01;
c) Levoxyl Tablets, (Levothyroxine Sodium Tablets) USP, 150mcg, 100 tablet bottles, Rx only.

DC 5260-4515-01;
d) Levoxyl Tablets, (Levothyroxine Sodium Tablets) USP, 200mcg, 100 tablet bottles, Rx only.

NDC 5260-4520-01;
CODE
a) Lot #030655, Expiration Date: May 31, 04;
b) Lot #030947, Expiration Date: JUL 31, 04;
c) Lot Numbers: 030656 and 031775, Expiration Date: JUL 31, 04;
d) Lot Numbers: 030348, 030654, 030704 and 031057, Expiration Date: JUL 31, 04.
RECALLING FIRM/MANUFACTURER Amerisource Health Services Corp., Columbus, OH.
REASON Subpotent (Stability).
VOLUME OF PRODUCT IN COMMERCE 41,371 bottles.
DISTRIBUTION Nationwide.


PRODUCT Member's Mark®, Pain Reliever, Fever Reducer, Acetaminophen 500 mg, Non Aspirin Extra Strength, 500 Caplets.

CODE Bulk Code BA0078AC, Lot Number: 3KB0745A.
RECALLING FIRM/MANUFACTURER Leiner Health Products, Carson, CA.
REASON Presence of foreign substance.
VOLUME OF PRODUCT IN COMMERCE 29,760 bottles, 500 count bottles.
DISTRIBUTION Nationwide.


PRODUCT Children's Motrin Tablets (Ibuprofen), 50 mg, 24 Grape-Flavored Chewable Tablets, Pain Reliever/Fever Reducer, over-the-counter.
CODE Lot number and expiration dates, respectively, JBM074 exp. 02/06; HSM192, exp 01/06; JBM006 exp. 02/06.
RECALLING FIRM/MANUFACTURER McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil-PPC, Inc., Fort Washington, PA.
REASON Mislabeling, printing defect on carton label dosing chart for ages 4-5 may incorrectly indicate 8 tablets instead of 3 tablets. Note: bottle label correctly indicates 3 tablets.
VOLUME OF PRODUCT IN COMMERCE 172,080 bottles of 24 tablets.
DISTRIBUTION Nationwide.


PRODUCT Diprivan (propofol) 1% Injectable Emulsion, 10mg/ml, 100 ml Vial, For IV administration, Sterile, Nonpyrogenic.
CODE Lot Number 4429J, expiration July 2005.
RECALLING FIRM/MANUFACTURER AstraZeneca Pharmaceuticals Lp, Newark, NJ.
REASON Presence of particulate matter.
VOLUME OF PRODUCT IN COMMERCE 11,234 vials.
DISTRIBUTION Nationwide.

 

PRODUCT Risperdal (Risperidone) Tablets, 3 mg, 60 count bottles, Rx only. NDC 50458-33006.

CODE Lot 3NG583, exp 11/05; Lot 4AG756, exp. 12/05.
RECALLING FIRM/MANUFACTURER Top Rx, Bartlett, TN.
REASON Adulterated; Presence of Foreign Tablets.
VOLUME OF PRODUCT IN COMMERCE 10 bottles.
DISTRIBUTION Nationwide.


PRODUCT
a) Abilify Tablets (aripiprazole), 5 mg, 30 count bottles, Rx only. NDC 59148-007-13.
b) Abilify Tablets (aripiprazole), 10 mg, 30 count bottles, Rx only. NDC 59148-008-13.
c) Abilify Tablets (aripiprazole), 15 mg, 30 count bottles, Rx only. NDC 59148-009-13.
d) Abilify Tablets (aripiprazole), 20 mg, 30 count bottles, Rx only. NDC 59148-010-13.
e) Abilify Tablets (aripiprazole), 30 mg, 30 count bottles, Rx only. NDC 59148-011-13.

CODE
a) Lot no. 3H65463;
b) Lot no. 3H65464;
c) Lot no. 3H65465;
d) Lot no. 3H65466 and 4D83127;
e) Lot no. 3H65467.
RECALLING FIRM/MANUFACTURER Bristol-Myers Squibb Company, New Brunswick, NJ.
REASON Dissolution Failure (9 month stability).
VOLUME OF PRODUCT IN COMMERCE 301,965 bottles.
DISTRIBUTION Nationwide.


PRODUCT ESTRACE Tablets, (estradiol tablets, USP), 1mg, 100 tablets, Rx only. NDC 0430-0023-24.
CODE Lot 4A79546 exp. 1/07.
RECALLING FIRM/MANUFACTURER Warner Chilcott Labs, Rockaway, NJ.
REASON Mislabeling: Outer carton incorrectly states contains 0.5mg estradiol whereas the bottle label correctly states contains 1.Omg estradiol.
VOLUME OF PRODUCT IN COMMERCE 2,348 bottles.
DISTRIBUTION Nationwide.


PRODUCT Amiodarone Hydrochloride Injection, 900 mg/18mL (50mg/ml) For IV use only, Rx only.
CODE
Lot # 494974 ­ Exp. Date: 09/2005;
Lot # 450492 and # 450492A, Exp. Date: 03/2005;
Lot # 475953 and # 475953A, Exp. Date: 03/2005.
RECALLING FIRM/MANUFACTURER Bedford Laboratories, Bedford, OH.
REASON Presence of particulate matter.
VOLUME OF PRODUCT IN COMMERCE 85,727 vials.
DISTRIBUTION Nationwide.

 

PRODUCT
a) Phenytek, brand of Phenytoin Sodium, USP 200 mg and 300 mg, extended release capsules. Labeled in part
***Physician Sample. Not to be sold. Rx only***. Packaged in bottles of 7, 10, and 30 capsules.
b) Kristalose brand of Lactulose, 10 mg and 20 mg single dose packets, for oral solution. Rx only. Packaged in
boxes of 30 packets.
c) Avita brand of Tretinoin Gel 0.025%, 2 gm tubes, for topical use only. Product labeled in part ***Physician
Sample*** Rx only***.
CODE
a) Lots: 2J2662 exp 8/31/2003 1K0076 exp 1/31/2004 1K0077 exp 1/31/2004 2J2666 exp 8/31/2004 1K0083 exp 1/31/2004 1K0084 exp 1/31/2004 1K0085 exp 1/31/2004;
b) Lots: S03060 exp 11/30/03 S02060 exp 11/30/03 S19050 exp 11/30/03 S01090 exp 11/30/03 S13070 exp 10/31/03 S11070 exp 10/31/03 S14070 exp 11/30/03;
c) Lot RFMM exp 11/30/02.
RECALLING FIRM/MANUFACTURER Bertek Pharmaceuticals, Inc., RTP, NC.
REASON Pharmaceuticals were distributed to physician offices beyond the labeled expiration date of the products.
VOLUME OF PRODUCT IN COMMERCE 13,586 units.
DISTRIBUTION Nationwide.


PRODUCT Amitriptyline HC1, 10mg, 100 and 1000 count bottles, Rx only, NDC #0603-2212-32 and NDC # 0603-2212-21.
CODE Lot #T018H03 and T019H03, exp. Date 08/05.
RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals Llc.
REASON Impurities: impurity level exceeded at the 9 month stability point.
VOLUME OF PRODUCT IN COMMERCE 4,697 bottles of 1000 and 45,435 bottles of 100.
DISTRIBUTION Nationwide.