OCTOBER 2003
WEEK ENDING OCTOBER 4
PRODUCT a) Albuterol Sulfate 0.083%, unit-dose vial containing Albuterol
Sulfate Inhalation Solution, Rx ONLY, Pre-mix solution for inhalation only, Distributed
and manufactured by Farmacia (Pharmacy) La Monserrate, Calle Munoz Rivera, Esq.
Monserrate, Aguas Buenas, PR. The units are packaged in white cardboard boxes
containing the vials needed by the patient for the month. The box has a custom
made, typewritten pharmacy label. At the other side of the box, there is
another label with the lot # and expiration date.
b)
Ipratropium Bromide 0.02%, unit-dose vial, pre-mixed solution for inhalation
only, Rx Only. The units are packaged in white cardboard boxes containing the
vials needed by the patient for the month. The box has a custom made,
typewritten pharmacy label in one side. At the other side of the box, there is
another label with the lot# and expiration date.
CODE
a) All codes manufactured and distributed between June and July 2003.
b) All codes manufactured and distributed between April and July 2003.
RECALLING FIRM/MANUFACTURER Monserrat Pharmaceuticals, Inc., Aguas
Buenas, PR.
REASON Good Manufacturing Practice deviations; including, but not limited
to, lack of testing for approval or release, stability data, and validation for
cleaning/manufacturing operations.
VOLUME OF PRODUCT IN COMMERCE 44,000.
DISTRIBUTION Puerto Rico.
PRODUCT
a)
Zyprexa Tablets (Olanzapine), 5 mg., 60-tablet bottles, Rx only, Eli Lilly and
Company, Indianapolis, IN.
b) Zyprexa Tablets (Olanzapine), 10 mg., 60-tablet bottles, Rx only, NDC
0002-4117-60, Eli Lilly and Company, Indianapolis, IN.
c) Zyprexa Tablets (Olanzapine), 15 mg., 60-tablet bottles, Rx only, NDC-0002-4115-60,
Eli Lilly and Company, Indianapolis, IN.
d) Zyprexa Tablets (Olanzapine) 20 mg., 60-tablet bottles, Rx only, Eli Lilly
and Company, Indianapolis, IN.
CODE
a) Lot Number 6AA66A;
b) Lot numbers 6AH19A, 7AA39A,and 7EA97A;
c) Lot Numbers 6AH35A, 6AG70A, 7AA77A, 7ED06A, 7ED00A, and 7EA53A;
d) Lot Numbers 7AA79A, 7EC85A, 7EA19A, and 7EA22A.
RECALLING FIRM D & K Healthcare Resources, Inc., Saint Louis, MO.
MANUFACTURER-UNKNOWN.
REASON Counterfeit: An unknown number of bottles bearing these lot
numbers are counterfeit, in that they have been repackaged, relabeled and/or
may contain different strengths or mixed strength tablets differing from their
labeled contents and/or bear extended expiration dates, as the source of the
repacked and/or relabeled bottles is unknown.
VOLUME OF PRODUCT IN COMMERCE 31,553/60-tablet bottles.
DISTRIBUTION Nationwide.
PRODUCT Oxygen, USP, compressed, steel and aluminum cylinderss C, D, E,
K, Dey, Filled by Southern Welding Supply, Inc., Savannah, GA. CODE Lot
Numbers 031081/4, 031082/5, 031901/4, 031901/5, 031901/3, 031911/4, 031911/5,
031921/3, 031921/4, 031921/5, 031951/4, 031951/5, 031952/4, 031952/5, 031961/4,
031961/5, 031971/3, 031971/4, 031981/3, 031981/4, 031981/5.
RECALLING FIRM/MANUFACTURER Southern Welding Supply, Inc., Savannah, GA.
REASON Good Manufacturing Practice (GMP's) deviations, including but not
limited to, failure to document testing of product purity in batch records.
VOLUME OF PRODUCT IN COMMERCE 573 cylinders.
DISTRIBUTION GA and SC.
PRODUCT M.T.E. - 6 Concentrated,
Mixture of Six Trace Elements Additive (Each mL providing: Zinc 5 mg, Copper 1
mg, Manganese 0.5 mg, Chromium 10 mcg, Selenium 60 mcg, Iodide 75 mcg), 10 mL
Multiple Dose Vial, Must Be Diluted Before IV Use, Rx only, American Pharmaceutical
Partners, Inc., Schaumburg, IL, NDC 63323-036-10.
CODE Lot numbers 100669 Expiration Date 8-30-03, 110316 Expiration Date
3-30-04 and 111223 Expiration Date 12-30-04.
RECALLING FIRM/MANUFACTURER American Pharmaceutical Partners, Inc.,
Melrose Park, IL.
REASON Subpotent (Iodide).
VOLUME OF PRODUCT IN COMMERCE 68,650 vials.
DISTRIBUTION Nationwide, Puerto Rico, and Canada.
PRODUCT Non-Aspirin Sinus Gelcaps, (Acetaminophen, 500mg and
Pseudoehedrine HCl, 30mg), 24 Gelcaps blister packed cartons, Extra Strength,
Pain Reliever/Nasal Decongestant, Pharmacist Formula is Marketed by: Leiner
Health Products Carson, CA -----Also sold under other brand names as ----Pain
Relief Sinus, Day Non-Drowsy, Extra Strength, Pain Reliever, Nasal
Decongestant, 24 Gelcaps blister packed cartons, Longs brand, Distributed by
Longs Drugs, Walnut Creek, CA----Non-Aspirin Sinus, Non-Drowsy, Extra Strength,
24 Gelatin Caplets blister packed cartons, American Fare brand, Made for Kmart
Corporation, Troy, Michigan----Non-Drowsy Sinus, Non-Aspirin, Maximum Strength,
Multi-Symptom Relief, Pain Reliever, Nasal Decongestant, 24 Gelatin Caplets
blister packed cartons, Eckerd brand, Distributed by Eckerd Drug Company
Clearwater, FL----Pain Reliever Sinus, Pain Reliever, Nasal Decongestant, Maximum
Strength, 24 Gelatin Tablets blister packed cartons, ElectHealth brand,
Distributed by: Shopko Stores, Inc. Green Bay, WI.
CODE Lot Numbers 3EB1154 (Eckerd), 3EB1156 (American Fare), 3EB0999
(Longs), 3EB1155 (Longs), 3EB1157 (Pharmacist Formula) & 3EB1000
(ElectHealth).
RECALLING FIRM/MANUFACTURER Leiner Health Products, Carlson, CA.
REASON Mislabeling; Extended expiration date-product incorrectly bears
expiry as 11/2005 rather than correct date of 12/2004.
VOLUME OF PRODUCT IN COMMERCE 864,000 pills.
DISTRIBUTION Nationwide.
PRODUCT Duradryl Jr. Capsules, Each T.D. Capsule contains:
(Phenylephrine HCl 10mg, Chlorpheniramine Maleate 4.0mg, Methscopolamine
Nitrate 1.25mg), 100 Capsule bottles, Rx Only, Dist. by: Breckenridge
Pharmaceuticals, Inc., Boca Raton, FL. NDC 51991-700-01
CODE Lot No. 046G3002.
RECALLING FIRM/MANUFACTURER Nutramed, Inc., Rahway, NJ.
REASON Dissolution failure; Phenylephrine HCI and Methscopolamine
Nitrate.
VOLUME OF PRODUCT IN COMMERCE 4,992 bottles.
DISTRIBUTION Nationwide
PRODUCT Oxygen, USP, compressed, cylinders (125 and 281-cubic ft), RX
only.
CODE Lot number 184SPO3018B-Exp date 07/03/08.
RECALLING FIRM/MANUFACTURER Air Liquide America LP, Houston, TX.
REASON Good Manufacturing Practices deviation; failure to maintain
cylinder fill and testing records.
VOLUME OF PRODUCT IN COMMERCE 36 cylinders.
DISTRIBUTION WA.
PRODUCT Glucophage XR tablets (metformin HCl extended release), 500 mg,
100 count bottles, Rx only, Distributed by: Bristol-Myers Squibb Company,
Princeton, NJ, NDC 0087-6063-13.
CODE Lot No. Exp. date 304622
Jan 2005 304623 Mar 2005 304624 Mar 2005 305518 Mar 2005 305519 Mar 2005 305520
Mar 2005 305521 Mar 2005 305522 Mar 2005 305523 Mar 2005 305524 Mar 2005 305525
Mar 2005 305526 Mar 2005 305527 Mar 2005 305528 Mar 2005 305529 Mar 2005 305530
Mar 2005 305531 Mar 2005 305532 Mar 2005 305535 Mar 2005.
RECALLING FIRM/MANUFACTURER Bristol-Myers Squibb Company, New Brunswick,
NJ.
REASON Subpotency; some tablets may contain less than the minimum
specification for potency (blend validation).
VOLUME OF PRODUCT IN COMMERCE 205,655 units.
DISTRIBUTION Nationwide
PRODUCT Haloperidol Injection, USP, 5 mg/mL, 1 mL vial, Rx Only, For
Intramuscular Use, Sterile; American Pharmaceutical Partners, Inc., Schaumburg,
IL: NDC 63323-474-01. The product was also sold under the AmeriNet Choice label:
Haloperidol Injection, USP, 5mg/mL, 1 mL vial, Rx Only, For Intramuscular use,
Sterile.
CODE Lot Numbers: APP label: 111010, 111139, 111178, 111217, 120231,
120264, 120359, 120447,120691, 120725, 120838, 120917, 121028, 121049, 121468,
130281;
AmeriNet Choice label: 111217, 120628, 121468 and 130281.
RECALLING FIRM/MANUFACTURER American Pharmaceutical Partners, Inc.,
Melrose Park, IL.
REASON Manufacturing Validation: The bulk solution mix time was not
completed as per the validated process time.
VOLUME OF PRODUCT IN COMMERCE 2,256,625 vials.
DISTRIBUTION Nationwide and Puerto Rico.
PRODUCT Evista Tablets (Raloxifene HCl), 60 mg, 7 tablets blister pack,
Rx Only.
CODE 7AA26P (1-FEB-2005), 6AE83P (1-OCT-2004), 6AE76P (1-AUG-2004),
6AD24N (1-JUN-2004), 6AD20N (1-JUN-2004), 6AA91P (1-MAR-2004), 6AA90N
(1-MAR-2004), 5AK53N (1-FEB-2004), 5AJ62N (1-DEC-2003), 5AJ51N (1-NOV-2003),
5AH97N (1-OCT-2003), 5AG47N (1-SEP-2003), 5AG39N (1-SEP-2003).
RECALLING FIRM/MANUFACTURER Lilly, Eli & Co., Indianapolis, IN.
REASON Mislabeling; Lot number and expiration date are not printed on
the external carton labeling.
VOLUME OF PRODUCT IN COMMERCE 13 sample pack lots.
DISTRIBUTION Nationwide, Cyprus, Lebanon, and Malta.
PRODUCT Amaryl tablets (Glimepiride), 4 mg, 100 tablet blister pack, Rx
Only.
CODE Lot number: 1054540.
RECALLING FIRM/MANUFACTURER Aventis Pharmaceuticals Inc., Kansas City,
MO.
REASON Dissolution failure: stability (18 month test station).
VOLUME OF PRODUCT IN COMMERCE 7,032/100-tab boxes.
DISTRIBUTION Nationwide.
PRODUCT Prozac Capsules Weekly (Fluoxetine Hydrochloride), Delayed
Release Capsules, 90 mg fluoxetine, 4 capsules blister pack, Rx Only. CODE 6RH73N
(1-NOV-2004), 6RH36N (1-OCT-2004), 6RC15P (1-AUG-2004), 6MF17R (1-JUL-2004),
6RA33V (1-AUG-2004), 6MG40N (1-AUG-2004), 5MX93N (1-FEB-2004), 5NC81N
(1-OCT-2003), 5MS53N (1-OCT-2003), 5MS52N (1-SEP-2003).
RECALLING FIRM/MANUFACTURER Lilly, Eli & Co., Indianapolis, IN.
REASON Mislabeling; Lot number and expiration date are not printed on
the external carton labeling.
VOLUME OF PRODUCT IN COMMERCE Unknown.
DISTRIBUTION Nationwide.