JULY 2002
WEEK
ENDING JULY 6
PRODUCT Opalescence Xtra Boost, chemically activated
whitening gel (38% hydrogen peroxide) for in office tooth whitening kit.
CODE Lot Numbers 4192 and 4LQ0.
RECALLING FIRM/MANUFACTURER Ultradent Products, Inc., South
Jordan, UT
REASON Cracks in syringe causing misapplication of hydrogen
peroxide.
VOLUME OF PRODUCT IN COMMERCE 260 kits.
DISTRIBUTION Nationwide.
PRODUCT Xylocaine 2% Jelly (lidocaine HCL), For Topical Use
Only, 20 mL syringe, Rx only, Sterile, Single Use Syringe, NDC 0186-0336-53.
CODE Lot Numbers: CB652 Exp 8/02; DA725 EXP 7/03.
RECALLING FIRM/MANUFACTURER Recalling Firm: Astrazeneca Pharmacuetical LP., Wilmington,
DE
Manufacturer: Astrazeneca Lquid production [LPS]
Karlskoga.
REASON Stability-super potency/low fill: Product may have low syringe fill volume and
high lidocaine assay.
VOLUME OF PRODUCT IN COMMERCE 51,740.
DISTRIBUTION Nationwide.
PRODUCT Methotrexate For Injection USP, 1 g, lyophilized,
preservative free 1 g Single Dose Vial, Sterile, Rx only, NDC #63323-122-50.
CODE Lot numbers: 210275-1, 210305-1, 210315-1, 210276-1,
210306-1, 210303-1, 210308-1, 210326-1, 210323-1.
RECALLING FIRM/MANUFACTURER Recalling Firm: American Pharmaceutical Partners, Inc.,
Melrose Park, IL
Manufacturer: Bigmar Pharmaceuticals, Bargengo,
Switzerland.
REASON Misbranding; The product is labeled with the wrong
NDC # and has a misspelled name.
VOLUME OF PRODUCT IN COMMERCE 29,361 vials.
DISTRIBUTION Nationwide.
PRODUCT Doxycycline Hyclate Capsules, 100mg, 500-count
bottles, Rx Only.
CODE
Lot
No. Exp. Date
2985-103511 12/00/04
RECALLING FIRM/MANUFACTURER Recalling Firm: Ivax Pharmaceuticals, Inc., Miami, FL
Manufacturer: Ivax Pharmaceuticals Caribe, Inc., Cidra,
Puerto Rico.
REASON Active ingredient fails to meet test specification
for related compounds.
VOLUME OF PRODUCT IN COMMERCE 3,601, 500-count bottles.
DISTRIBUTION Nationwide.
WEEK ENDING JULY 13
PRODUCT Intralipid 20%, (20% I.V. Fat Emulsion), For
Intravenous Use, 500 mL bottles, Rx only, NDC 0336-0491-03.
CODE Lot numbers MSI0205, NR66055, NR66056, NR66057,
NR66058, NR66059, NR66062, NR66063.
RECALLING FIRM/MANUFACTURER Fresenius Kabi, Clayton, NC
REASON Particulates:
bottles may contain dark tan to brown particulate matter.
VOLUME OF PRODUCT IN COMMERCE 25,200 units.
DISTRIBUTION Nationwide
PRODUCT Premarin (conjugated estrogens tablets USP) 1.25 mg
tablets, 100, 1000 and 5,000-tablet bottles.
CODE NDC #:
0046-0866-91 (bottles of 1000) Lot #s: 9000353, exp. 11/04 and 9000681,
exp. 11/04
RECALL
EXTENDED ON 6/18/02 to the following 3 lots NDC #: 0046-0866-81 (bottles of
100) Lot #: 9000477, Exp. 1/05
Distribution
dates: 6/12/00-8/17/01 Quantity distributed: 31,310 bottles
NDC
#: 0046-0866-91 (bottles of 1000) Lot
#: 9000682, Exp. 1/05 Distribution
dates: 7/10/00 - 5/2/01 Quantity distributed: 2,132 bottles
NDC
#: 0046-0866-95 (bottles of 5000) Lot
#: 9000481, Exp. 1/05 Distribution
dates: 7/6/00 - 3/13/01 Quantity distributed: 1,308 bottles.
RECALLING FIRM/MANUFACTURER Recalling Firm: Wyeth-Ayerst Laboratories, Richmond, VA
Manufacturer: Ayerst Laboratories, Inc., Rouses Point, NY.
REASON Failure to meet dissolution specifications.
VOLUME OF PRODUCT IN COMMERCE 34,750 bottles.
DISTRIBUTION Nationwide.
PRODUCT Levoxyl Tablets (Levothyroxine Sodium Tablets, USP)
50 mcg (0.05 mg), Rx only, 100 and 1,000 tablet bottles,
Daniels
Pharmaceuticals, St. Petersburg, FL.
Levoxyl Tablets (Levothyroxine Sodium
Tablets, USP) 75 mcg (0.075 mg), Rx only, 100 and 1,000 tablet bottles,
Daniels
Pharmaceuticals, St. Petersburg, FL.
Levoxyl
Tablets (Levothyroxine Sodium Tablets, USP) 88 mcg (0.088 mg), Rx only, 100 and
1,000 tablet bottles,
Daniels
Pharmaceuticals, St. Petersburg, FL.
Levoxyl
Tablets (Levothyroxine Sodium Tablets, USP) 100 mcg (0.1 mg), Rx only, 100 and
1,000 tablet bottles,
Daniels
Pharmaceuticals, St. Petersburg, FL.
CODE 50 mcg, 100 tablet bottle: Lot Nos. 6533, 6534,
6567, 6568, 6569, 6570 (exp 05/02); 6571 (Exp 06/02); 6623, 6624, 6626, 6627,
6628 (Exp 07/02); 6648, 6649, 6651, 6652, 6658, 6660 (Exp 08/02); 6732, 6736,
6737, 6738, 6740 (Exp. 10/02); 6771,
6772, 6795, 6796, 6797 (Exp 11/02);
50
mcg, 1000 tablet bottle: Lot Nos. 6572, 6573 (Exp 06/02); 6650, 6659, 6661,
6662 (Exp 08/02); 6733, 6735, (Exp 10/02); 6773 (Exp 11/02);
75
mcg, 100 tablet bottle: Lot Nos. 6542, 6543, 6574, 6576 (Exp 06/02); 6633 (Exp
07/02); 6634, 6635, 6636, 6637 (Exp 08/02); 6694, 6695, 6696, 6698, 6699, 6701,
6702, 6703, (Exp 09/02); 6753, 6754, 6755, 6756 (Exp 10/02);
75
mcg, 1000 tablet bottle: Lot Nos. 6578 (Exp 07/02); 6638 (Exp 08/02); 6697,
6700 (Exp 09/02); 6807 (Exp 11/02); 88 mcg, 100 tablet bottle: Lot Nos. 6538,
6539, (Exp 05/02); 6593 (Exp 06/02); 6646 (Exp 07/02); 6668, 6669, 6670 (Exp
08/02); 6769, 6770, 6802, 6803 (Exp 11/02);
88
mcg, 1000 tablet bottle: Lot Nos. 6538 (Exp 05/02); 6668 (Exp 08/02); 6802 (Exp
11/02)
100
mcg, 100 tablet bottle: Lot Nos. 6555, 6556, 6557, 6562, 6563, 6564 (Exp
05/02); 6603, 6604, 6605, 6606 (Exp 06/02); 6645, 6716, 6718, 6722 (Exp 09/02);
6726, 6727, 6728, 6729 (Exp 10/02); 6764 (Exp 11/02);
100
mcg, 1000 tablet bottle: Lot Nos. 6613, 6614, 6615, 6616, 6617, 6618, 6631,
6632 (Exp 07/02); 6642, 6643, 6644, 6717, 6719, 6723 (Exp 09/02); 6724, 6725,
6761, 6762 (Exp 10/02); 6763 (Exp 11/02).
RECALLING FIRM/MANUFACTURER Recalling Firm: King Pharmaceuticals, Inc., Bristol, TN
Manufacturer: King Pharmaceuticals, Inc., St. Petersburg,
FL.
REASON Lack of assurance product will maintain potency throughout
its labeled expiration date.
VOLUME OF PRODUCT IN COMMERCE 2,885,015 units.
DISTRIBUTION Nationwide and Internationally.
PRODUCT Pulmicort Turbuhaler (budesonide inhalation powder)
200 mcg 60 Metered Doses For Oral Inhalation, Professional Sample.
CODE Lot Numbers: CK1524, CK1527, CK1539, CK1547- Exp.
Date Apr-03 CL1555, CL1560, CL1562, CL1564, CL1566-Exp. Date May-03
CM1589-
Exp. Date Jun-03.
RECALLING FIRM/MANUFACTURER Recalling Firm: Astrazeneca, Wilmington, DE
Manufacturer: Astrazeneca Liquid Production, Sodertalje,
Sweden
REASON The turbuhaler may deliver a super-potent dose.
VOLUME OF PRODUCT IN COMMERCE 200,000.
DISTRIBUTION Nationwide.
WEEK ENDING JULY 20
PRODUCT
Combivir Tablets (lamivudine 150
mg/zidovudine 300 mg) 60 tablet bottles, NDC #0173-0595-00, GlaxoWellcome.
CODE
Lots 1ZP0848, 1ZP2346, 1ZP2347.
RECALLING
FIRM/MANUFACTURER Recalling Firm: Alliance Wholesale Distributor, Richton
Park, IL,
REASON
Counterfeit: bottles labeled to contain Combivir tablets may contain Ziagen tablets.
VOLUME
OF PRODUCT IN COMMERCE 1,756 bottles.
DISTRIBUTION IL, CA, IN, NY, TN, PA, MD and NJ.
WEEK ENDING JULY 27
PRODUCT Oxygen, USP, compressed, E, M, & D-size
cylinders, Rx only. The responsible firm on the label is Medirate Professional
Pharmacy,
Inc. dba Medicate Home Care Equipment, Farmington, MO.
CODE Cylinders coded 050102** through 061702** (** =
batch number assigned consecutively for each lot of cylinders filled that day).
RECALLING FIRM/MANUFACTURER Medicate Home Care
Equipment, Farmington, MO
REASON Good Manufacturing Practice deviations (GMP) and
reports of an ammonia odor.
VOLUME OF PRODUCT IN COMMERCE 1,320 cylinders.
DISTRIBUTION Missouri.
PRODUCT Desyrel Tablets (trazodone HCL tablets, USP), 100
mg, Rx only, packaged in bottles of 100 tablets (NDC 0087-0776-41) and 1,000
tablets
(NDC 0087-0776-43).
CODE 2 Lots MLS08 and MKC09.
RECALLING FIRM/MANUFACTURER Bristol-Myers Squibb Co.,
Evansville, IN
REASON Lack of content uniformity-subpotent at 18 month
stability.
VOLUME OF PRODUCT IN COMMERCE 2 Lots MLS08 and MKC09.
DISTRIBUTION Nationwide.
PRODUCT Colrex Compound Capsules, 100 capsule bottles, Rx
Only, (Codeine Phosphate 16 mg, Acetaminophen 325 mg, Phenylephrine
Hydrochloride
10 mg, Chlorpheniramine Maleate 2 mg). NDC # 55499-0840-1.
CODE Lot H000449A.
RECALLING FIRM/MANUFACTURER Mikart, Inc. Atlanta, GA
REASON Low weight capsules.
VOLUME OF PRODUCT IN COMMERCE 1853 bottles.
DISTRIBUTION NJ.
PRODUCT Esgic-Plus Capsules (Butalbital, Acetaminophen and
Caffeine Capsules, USP) 50 mg/500 mg/40 mg, 100 and 500 count bottles,
Rx
only, NDC# 0456-0679-01 and 0456-0679-02.
CODE Lots
D010201A, D010202A, D010203B, J010602A, J010603B and L010742A
RECALLING FIRM/MANUFACTURER Mikart, Inc. Atlanta, GA
REASON Low weight dosage units.
VOLUME OF PRODUCT IN COMMERCE 23,081/100 ct. bottles;
966/500 ct. bottles.
DISTRIBUTION MO.