MARCH 2005
WEEK ENDING MARCH 5
PRODUCT
Ultra Flu and Ultra Cap, Nasal Decongestant, Cough Suppressant, Antihistamine,
(500 mg acetaminophen, 15 mg dextromethorphan HBr, 2 mg chlorpheniramine
maleate)
Pain Reliever, Fever Reducer, 25 tablets per bottle, NDC #11383-227-25 and NDC
#11383-226-25.
CODE
Lot #4293, Exp. 9/05.
RECALLING FIRM/MANUFACTURER
Weeks & Leo, Co., Inc., Urbandale, IA
REASON
Labeling: Label lacks the declaration of pseudoephedrine HCI 30 mg.
VOLUME OF PRODUCT IN COMMERCE
2,342/25-tablet bottles.
DISTRIBUTION
Nationwide.
PRODUCT
a) Pramosone cream 1% (hydrocortisone acetate 1%
and pramoxine HCl 1%) packaged in 3 gram
professional sample size metal tubes; Rx only,
NDC 0496-0716-33.
b) Pramosone cream, 2.5% (hydrocortisone acetate
2.5% and pramoxine HCl 1%), packaged in 3 gram
professional sample size metal tubes; Rx only,
NDC 0496-0717-33.
CODE
a) Lot 03083B, Exp. 04/05;
b) Lot 030909A, Exp. 04/05;
Lot 03229A, Exp. 10/05 and
Lot 04047A, Exp. 03/06.
RECALLING FIRM/MANUFACTURER
Ferndale Laboratories, Inc., Ferndale, MI.
REASON
Defective container: The metal tubes may have pinhole defects, which would result
in a super potent product.
VOLUME OF PRODUCT IN COMMERCE
561,260 tubes.
DISTRIBUTION
Nationwide.
PRODUCT
a) Imodium Advanced Caplets (Loperamide HCl 2 mg /Simethicone 125 mg). The product is packaged in a
p ouch containing 2 caplets.
b) Imodium Advanced Caplets (Loperamide HCl 2mg/Simethicone 125 mg), The product is packaged in
bottles containing 42 caplets.
CODE
a) Lot #HPC025, exp. 10/31/05;
b) Lot #JHF082, exp. 6/30/06.
RECALLING FIRM/MANUFACTURER
McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil PPC, Inc.,
Fort Washington, PA.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
258,750 pouches and 36,888 bottles.
DISTRIBUTION
Nationwide.
WEEK ENDING MARCH 12
PRODUCT
CombiPatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg
per day, Rx only.
CODE
Lot 7364101, Exp. April 2005.
RECALLING FIRM/MANUFACTURER
Novartis Pharmaceuticals, Corp, East Hanover, NJ
REASON
Impurities/Degradation Products.
VOLUME OF PRODUCT IN COMMERCE
20,057 packers (3 cartons of 8 units per carton).
DISTRIBUTION
Nationwide.
PRODUCT
Vitrase (hyaluronidase injection) Ovine, 200 USP Units/mL, Rx only.
CODE
Lot W0002422.
RECALLING FIRM/MANUFACTURER
ISTA Pharmaceuticals Inc, Irvine, CA
REASON
An unvalidated and unapproved filter for final sterile filtration of the product
appears to have been used in the manufacture of the lot.
VOLUME OF PRODUCT IN COMMERCE
4,446.
DISTRIBUTION
Nationwide.
PRODUCT
Junior's chewable (acetaminophen 160 mg) tablets, USP in 20 tablet bottles,
bubblegum flavor labeled as Life brand, OTC,
CODE
Lots 3KE0967, 3KE0674, 4AE0013, 4AE0775 and 4BE0421; Exp. 09/15/2005.
RECALLING FIRM/MANUFACTURER
Perrigo Company, Allegan, MI
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
50,268 bottles.
DISTRIBUTION
Canada.
PRODUCT
Effervescent antacid and pain medication (aspirin 325 mg, citric acid 1000 mg
and sodium bicarbonate 1916 mg), in 36 and 72 effervescent tablet packages packaged
under Good Sense brand. Also sold under other brands as: American Fare brand;
Eckerd brand; Equate brand; Family Dollar brand; Kroger brand; Major brand;
Meijer brand; Pathmark brand; Rite Aid brand; Safeway brand; Today's Health
brand; Top Care brand, and Western Family brand.
CODE
Lots 3EP0066, 3EP0067, 3EP0074, 3EP0075, 3EP0076, 3FP0001, 3FP0002, 3FP0003,
3FP0076, 3GP0001, 3GP0002, 3GP0026.
RECALLING FIRM/MANUFACTURER
Perrigo Company, Allegan, MI
REASON
Stability Failure: The product exceeded the firm's specification for salicylic
acid at the 18 month stability period.
VOLUME OF PRODUCT IN COMMERCE
109,804 packages.
DISTRIBUTION
Nationwide.
WEEK ENDING MARCH 19
PRODUCT
a) Nefazodone HC1 Tablets, 50 mg, 100 count blister
packs, Rx only.
b) Nefazodone HC1 Tablets, 100 mg, 100 count blister
packs, Rx only.
c) Nefazodone HC1 Tablets, 150 mg, 100 count blister
packs, Rx only.
d) Nefazodone HC1 Tablets, 200 mg, 100 count blister
packs, Rx only.
CODE
a) Lot 118557A, Exp. Date 6/2005;
b) Lot 118550, Exp. Date 7/2005;
c) Lot 118552, Exp. Date 6/2005;
d) Lot 118555, Exp. Date 7/2005;
RECALLING FIRM/MANUFACTURER
Ivax Pharmaceuticals, Inc., Northvale, NJ
REASON
Dissolution Failure: Lots may fail to meet requirements for dissolution throughout
expiration.
VOLUME OF PRODUCT IN COMMERCE
50 mg-949 units; 100 mg 937 units; 150 mg-1348 units, 200 mg-1316 units.
DISTRIBUTION
Nationwide.
Nationwide Alert on ONE lot of Pharmedium Services magnesium sulfate solution
Nationwide alert has been issued against the use of PharMEDium Services Magnesium Sulfate 1 gram in 50mL D5W (piggyback) IV solution, lot number 100504900049 and expiration date 4/4/05. This product is manufactured by PharMEDium Services of Houston, Texas and may be contaminated with Serratia marcescens bacteria that can cause serious, life-threatening illness in patients with compromised immune systems.
This product is frequently administered intravenously to patients undergoing cardiac surgery and was apparently distributed to several hospitals around the country. To date it has been associated with at least 5 recent cases of Serratia marcescens infection in a hospital in New Jersey. All patients have responded to treatment with antibiotics and are reportedly recovering well.
Hospitals with questions may contact the company at 1-847-457-2300. Persons wanting to report anything to the Food and Drug Administration regarding this products may contact FDA's MedWatch office at 1 800-FDA-1088.
WEEK ENDING MARCH 26
PRODUCT
a) Health & Herbs Eye Rinse Concentrate Formula
1036 Herbal Tincture in 2 fl. oz. amber bottles with black glass dropper.
b) White Willow Bark (3193) Herbal Tincture in 2 fl.
oz. amber bottles with black glass dropper.
c) Fennel Seed 3126 Herbal Tincture in 2 fl.
oz. amber bottles with black glass dropper
and 8 oz. bottles.
d) Elderberry Flower 3247 Herbal Tincture in 2 fl.
oz. amber bottles with black glass dropper and 32 oz glass bottle.
CODE
Not all bottles are coded. Some of the bottles have fill dates on them, however
the dating system used by each employee was not systematic.
RECALLING FIRM/MANUFACTURER
Alternative Health & Herbs Remedies, Albany, OR
REASON
Non-Sterility.
VOLUME OF PRODUCT IN COMMERCE
a) 87/2 oz. bottles;
b) 41/2 oz. bottles;
c) 35/2 oz. bottles and 1/8 oz bottle;
d) 8/2 oz. and 1/32 oz. bottles.
DISTRIBUTION
Nationwide.
PRODUCT
BioTouch Instant Numb Topical Anesthetic Ointment, 12 grams, labeled to contain
4% Lidocaine and 15% Benzocaine.
CODE
Lot numbers 95396 and 95393.
RECALLING FIRM/MANUFACTURER
Coats Aloe International, Inc, Garland, TX
REASON
Potency: Super-potent for Lidocaine and sub-potent for benzocaine based on labeled
quantities.
VOLUME OF PRODUCT IN COMMERCE
3,381 bottles.
DISTRIBUTION
CA.
PRODUCT
Ibuprofen Tablets USP, 400mg, 500 ct bottles, NDC # 0591-4010-05 and 100 ct
bottles, NDC # 0591-4010-01, Rx only.
CODE
Lot # 23248, Exp. 8-2007;
Lot # 23045, Exp. 8-2007.
RECALLING FIRM/MANUFACTURER
BASF Corporation, Shreveport, LA
REASON
Adulterated; Foreign tablets co-mingled in a package lot of ibuprofen tablets.
VOLUME OF PRODUCT IN COMMERCE
20,124 bottles of 500 ct;
13,056 bottles of 100 ct.
DISTRIBUTION
CA.
PRODUCT
APRI (desogestrel and ethinyl estradiol) Tablets, 0.15 mg/0.03 mg, 28 Day Regimen,
Oral Contraceptive. Rx only. NDC # 0555-9043-58. .
CODE
Lot #590434045, Exp. date: 12/06.
RECALLING FIRM/MANUFACTURER
Barr Pharmaceuticals, Inc., Cincinnati, OH
REASON
The individual 28 count tablet blister pack may be packaged upside down in the
printed card package that is placed over the blister pack. The "start"
row contains white placebo tablets instead of rose colored active tablets.
VOLUME OF PRODUCT IN COMMERCE
67,512 blister cards.
DISTRIBUTION
Nationwide.
PRODUCT
Pfizer brand Dalacin T Gel 1%, clindamycin phosphate, in tubes 10g X 10, Rx
only, Product is labeled in Japanese.
CODE
Lots 27MCC and 14MCM; Exp. April 2006.
RECALLING FIRM/MANUFACTURER
Pfizer, Inc., Kalamazoo, MI
REASON
Presence of foreign substance: Insect contamination.
VOLUME OF PRODUCT IN COMMERCE
14,090 tubes.
DISTRIBUTION
Japan.