Recent Drug & Medicine Recalls

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Recent Drug and Medicine Alerts

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Recent Drug and Medicine Alerts

 

Last Update November 8, 2001

 

Carlsbad Technology Recalls Hyoscyamine Sulfate, USP, Extended

Release Capsules Nov 8

Reason: Sub-potency (9 month stability station).

Distribution: OH.

 

Alpharma Recalls Bronchial Mist, Epinephrine Inhalation Aerosole

Nov 8

Reason: Dosage Uniformity Failure.

Distribution: TN, IN, CT, KY, and RI.

 

Paddock Laboratories Recalls Colocort, Hydrocortisone Enema Nov 8

Reason: Impurity specification failure at stability testing (18

months).

Distribution: Nationwide.

 

York Pharmaceuticals Recalls Burn relief spray Nov 8

Reason: Burn Relief Spray active ingredient Benozocaine is

super-potent --Antiseptic Spray active ingredient Lidocaine is sub-potent.

Distribution: NY, CA, FL, CO, IL, TN, GA, and FL.

 

Prestige Packaging Recalls Zestril Tablets (lisinopril), 10 mg Nov

8

Reason: Mispackaging; Bottles labeled as 10 mg may contain 20 mg

tablets.

Distribution: MI and OH.

 

American Pharmaceutical Partners Recall various injection solutions

Nov 8

Reason: Lack of assurance of sterility.

Distribution: Nationwide and Canada.

 

Crompton Corporation Recalls Sentry Simethicone Emulsion Oct 18

Reason: Failed USP Defoaming Test.

Distribution: NY, OH, NJ, MO, Fl.

 

McNeil Consumer Healthcare Recalls Women's Tylenol Menstrual Relief

Caplets Oct 18

Reason: Dissolution Failure - Acetaminophen component (STABILITY).

Distribution: Nationwide.

 

Taro Pharmaceutical Recalls Etodolac Capsules Oct 18

Reason: Misbranded: Product label incorrectly declares product as

tablets.

Distribution: PA and KY.

 

PL Developments Recalls Motion Sickness (Meclizine HCl 25 mg)

Tablets Oct 18

Reason: Dissolution Failure.

Distribution: CA, FL and OH.

 

Air Liquide America Recalls Compressed Oxygen Oct 18

Reason: Misbranded: Cylinders were shipped empty or partially

filled.

Distribution: FL.

 

King Pharmaceuticals Recalls Levoxyl(Levothyroxine Sodium

Tablets,USP) Oct 18

Reason: Subpotency (During Stablity).

Distribution: Nationwide.

 

Able Laboratories Recalls Nitro Tab (Nitroglycerin Tablets, USP) Oct

18

Reason: Mislabeled: 0.3 MG Product Labeling (Exterior Carton )

incorrectly declares bottles to contain 0.4 MG. tablets.

Distribution: OH.

 

Schering Recalls Etrafon Tablets Oct 18

Reason: Dissolution Failure (18 Month Stability).

Distribution: Nationwide.

 

CIS-US, Inc. Recalls Pulmolite Kit Oct 18

Reason: Lack of assurance of sterility (Crimp seal problems).

Distribution: Nationwide.

 

CIS-US, Inc. Recalls Pulmolite Kit Sep 28

Reason: Lack of assurance of sterility (Crimp seal problems)

Distribution: Nationwide.

 

Advance Pharmaceutical Recalls Rugby Brand Diphenhist CAPTABS,

Antihistamine Sep 28

Reason: Carton labeling incorrectly lists inactive ingredients

including but not limited to – color additives.

Distribution: GA.

 

M.E. Pharmaceuticals Recalls Ferocon Capsules, Vinatal Forte and

Vinate Advanced Sep 28

Reason: Subpotent for Folic Acid.

Distribution: TN.

 

Kinray, Inc Recalls DIFLUCAN®(Fluconazole Tablets), 100 mg. Sep 28

Reason: Counterfeit .

Distribution: NY, NJ, PA, CT, MA, RI.

 

Wendt Laboratories Recalls TRAV-L-TABS (Meclizine HCl) 25 mg per

tablet Sep 20

Reason: Production Validation Deviation.

Distribution: ID, IL, NE, WI.

 

Wyeth Ayerst Pharmaceuticals Recalls Premarin Tablets,(Conjugated

Estrogen Tablets USP) 1.25 mg. Sep 20

Reason: Dissolution Failure.

Distribution: AL, FL, NJ, NY, OH, TN, and TX.

 

Schering Corp. Recalls Temodar 250mg Capsules (Temozolomide) Sep 20

Reason: Under Filled Capsules.

Distribution: Nationwide.

 

Novartis Pharmaceuticals Recalls Tegretol® (Carbamazepine USP) 200

mg tablets Sep 20

Reason: Dissolution Failure.

Distribution: Nationwide and Puerto Rico.

 

Perrigo Company Recalls Three Children's Pain Reliever Brands Sep

20

Reason: Super-potent (ACETAMINOPHEN).

Distribution: Nationwide.

 

Solvay Pharmaceuticals Recalls LITHOBID Slow-Release Tablets Sep 6

Reason: Dissolution Failure.

Distribution: Nationwide.

 

OxyCare Recalls Compressed Oxygen Sep 6

Reason: Sub-Potent.

Distribution: PA and NJ.

 

Merck Sharp & Dohme Quimica de PR Recalls Vioxx Sep 6

Reason: Fails to declare container is not intended for dispensing

and not child resistant.

Distribution: Nationwide.

 

Dercher Recalls Monsel Solution Sep 6

Reason: Super-Potent for Iron Content.

Distribution: CA, CT, IA, IL, IN, MD, ME, MI, MN, MO, ND, NY, OH,

PA, and WA.

 

Nittany Pharmaceuticals, Inc. Recalls 200 mg Caffeine tablets Sep 6

Reason: There is no data to support labeled expiry date.

Distribution: PA.

 

Nittany Pharmaceuticals, Inc. Recalls 150 mg Caffeine tablets Sep 6

Reason: There is no data to support labeled expiry date.

Distribution: PA.

 

Schering Corp. Recalls VANCERIL Inhalers Sep 6

Reason: Lack of assurance that canisters/product can meet potency

specifications

Distribution: 44 states Nationwide.

 

Hawkins Chemical Inc.Recalls Clonidine HCI, USP Sep 6

Reason: Records Do Not Correspond to Amounts of Product Distributed.

Distribution: Nationwide.

 

Novartis Recalls Tegretol® Tablets Sep 6

Reason: Dissolution failure.

Distribution: Nationwide.

 

All That's Natural II Recalls MSM Eyes and Nasal Drops. Sep 6

Reason: MICROBIAL CONTAMINATION (Pseudomonas mendocina/Klebsiella

pneumoniae).

Distribution: Nationwide.

 

Ultra Botanicals recalls MSM Eyes and Nasal Drops. Sep 6

Reason: MICROBIAL CONTAMINATION (Pseudomonas mendocina/Klebsiella

pneumoniae).

Distribution: Nationwide.

 

Yellow Rockets Tablets Recalled Aug 30

Reason: There is no Data to support labeled EXPIRY DATE.

Distribution: IA.

 

LORAZEPAM Tablets Recalled Aug 30

Reason: Container defect.

Distribution: Nationwide.

 

Fluocinolone Acetonide Ointment Recalled Aug 30

Reason: Lack of Homogeneity Leading to Super-Potency.

Distribution: Nationwide.

 

Nutrapin AQ Recalled Aug 23

Reason: Counterfeit.

Distribution: CA and GA.

 

Multiple Brands of liquid antacid Recalled by York Pharmaceuticals

Inc. Aug 23

Reason: Total aerobic microbial count failures and lack of

preservative effectiveness testing.

Distribution: OK, MS, MO, MD, CA, OR, AR, ND, NY, and OH.

 

Roxane Laboratories Inc. Recalls Alupent and Metaproterenol Sulfate

Inhalation Solution Aug 23

Reason: Lack of assurance of sterility (CGMP Deviations).

Distribution: AL, AK. AZ, CA, CO, CT, FL, HI, ID, IL, KY, LA, MA,

MN, MS, MO, NC, NM, NJ, NY,OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI.

 

Dynabac Tablets Recalled Aug 23

Reason: Related substance test failure at stability (12 Month).

Distribution: Nationwide.

 

Nittany Pharmaceuticals, Inc. Recalls White with Blue Specks Aug 23

Reason: No data to support labeled expiry date.

Distribution: PA.

 

Yellow Rockets Tablets Recalled Aug 23

Reason: No data to support labeled expiry date.

Distribution: IA.

 

Zenith Goldline Pharmaceuticals Recalls Perphenazine Tablets Aug 23

Reason: Tablet discoloration.

Distribution: Nationwide.

 

Cortizone 10 Plus Creme Recalled Aug 23

Reason: Product is cross-contaminated with the firm's Ben-Gay

Product.

Distribution: Nationwide.

 

Eco Dent Ultimate Natural Daily Rinse Recalled

Aug 2

Reason: May be contaminated with Pseudomonas alcaligenes and

Pseudomonas baleurica.

Distribution: AR, AZ, CA, CO, FL, IA, IN, NH, NJ, NY, OH, OR, TX,

VT, WI, Canada and Australia.

 

Vintage Pharmaceuticals Inc. Recalls Levothyroxine Sodium Jul 26

Reason: Stability and potency problems through the expiry dates.

Distribution: Nationwide.

 

 

 

 

 

 

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