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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 17141–17160 of 17,860 recalls

Class IIITerminated

Balziva(TM) (norethindrone and ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 28 day regimen, Rx only, Barr Laboratories, Inc., Pomona, NY --- NDC 0555-9034-58

Teva Pharmaceuticals USA, Inc.

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

March 15, 2013 · DrugView details →

Class ITerminated

Magnesium Sulfate 2 grams in Dextrose 5% for Injection, in 50 mL Plastic Infusion Bags, Med Prep Consulting Inc., Tinton Falls, NJ 07712

Med Prep Consulting, Inc.

Non-Sterility; mold contamination

March 14, 2013 · DrugView details →

Class IITerminated

All Compounded Products, packaged in plastic infusion bags, devices, syringes and glass vials, Med Prep Consulting Inc., Tinton Falls, NJ 07712

Med Prep Consulting, Inc.

Lack of Assurance of Sterility; potential for mold contamination

March 14, 2013 · DrugView details →

Class IIITerminated

Seasonale(R) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg, 3 extended-cycle tablet dispensers, 91 tablets each, Rx only, TEVA Women Health, Inc., Subsidiary of TEVA Pharmaceuticals USA, Inc., Sellersville, PA NDC 51285-058-66

Teva Pharmaceuticals USA, Inc.

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing

March 14, 2013 · DrugView details →

Class IIITerminated

Camrese(TM) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg and Ethinyl Estradiol 0.01 Tablets, 2 Extended-Cycle Tablet Dispensers (NDC 0093-3134-82) and 1 Extended-Cycle Tablet Dispenser NDC 0093-3134-91), 91 Tablets Each, Rx only, TEVA Womens Health Inc., Subsidiary of TEVA Pharmaceuticals, Inc., Sellersville, PA

Teva Pharmaceuticals USA, Inc.

Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing

March 14, 2013 · DrugView details →

Class IIITerminated

Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 0.15 mg/0.03 mg, 91-count tablets per extended-cycle tablet dispenser packaged in 3 dispensers per carton, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-9123-66.

Teva Pharmaceuticals USA, Inc.

Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.

March 12, 2013 · DrugView details →

Class IIITerminated

Liothyronine Sodium Tablets, USP, 5 mcg Rx ONLY, 100 count bottle, Distributed by: Paddock Laboratories, Inc., Minneapolis, MN 55427, NDC 0574-0220-01,

L. Perrigo Co.

Failed Impurities/Degradation Specifications: 3 month stability testing.

March 12, 2013 · DrugView details →

Class IIITerminated

Portia (levonorgestrel and ethinyl estradiol) Tablets, USP, 0.15 mg/0.03 mg, 28-count tablets (containing 21 pink tablets followed by 7 white tablets) per blister card packaged in 6 blister cards per carton, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-9020-58.

Teva Pharmaceuticals USA, Inc.

Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.

March 12, 2013 · DrugView details →

Class IITerminated

Aniracetam and Choline, Aniracetam 460 mg, Choline 76 mg, 180 capsules per bottler, non-Rx, distributed by BoostYourGrade, BoostYourGrade, LLC Orlando, FL

Palmer Natural Products

Marketed Without an Approved NDA/ANDA: The products are unapproved drugs

March 11, 2013 · DrugView details →

Class IITerminated

Brain Defogger, Piracetam 390mg Choline 104mg capsules, 100 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. .

Palmer Natural Products

Marketed Without an Approved NDA/ANDA: The products are unapproved drugs

March 11, 2013 · DrugView details →

Class IITerminated

Oxiracetam & Choline , Oxiracetam 460mg Choline 110mg capsules a) 30 count bottle, b) 60 count bottle, c) 90 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. 32826

Palmer Natural Products

Marketed Without an Approved NDA/ANDA: The products are unapproved drugs

March 11, 2013 · DrugView details →

Class IITerminated

Aniracetam & Choline capsules, 430mg Aniracetam 88mg Choline, a) 30 count bottle b) 60 count bottle, c) 90 count, d) 180 count , OTC, BoostYourGrade, LLC Orlando, FL 32826

Palmer Natural Products

Marketed Without an Approved NDA/ANDA: The products are unapproved drugs

March 11, 2013 · DrugView details →

Class IITerminated

NOOTROPA COGNITIVE ENHANCEMENT SUPPLEMENT, 400 mg Aniracetam Capsules 60 count bottle, OTC Manufactured & Packaged in the USA for NOOTROPA.COM. DEVELOPED BY: Digital Superfuture Limited Arntel Building 9B 148 Des Voeux Rd. Hong Kong.

Palmer Natural Products

Marketed Without an Approved NDA/ANDA: The products are unapproved drugs

March 11, 2013 · DrugView details →

Class IITerminated

BoostYourGrade.com, Piracetam 390mg Choline 104mg capsules, 250 count bottle, OYC, BoostYourGrade, LLC, Orlando, FL 32826

Palmer Natural Products

Marketed Without an Approved NDA/ANDA: The products are unapproved drugs

March 11, 2013 · DrugView details →

Class IIITerminated

Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-889-15, UPC 3 50383-889-15 1.

Hi-Tech Pharmacal Co., Inc.

Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.

March 11, 2013 · DrugView details →

Class IITerminated

Piracetam & Choline, 390mg Piracetam 104mg Choline Capsules, a) 30 count bottle, b) 100 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. 32826 ,

Palmer Natural Products

Marketed Without an Approved NDA/ANDA: The products are unapproved drugs

March 11, 2013 · DrugView details →

Class IITerminated

Avastin, (0.05 ml, 1.25 mg/0.05ml), single unit dose syringes, Clinical Specialties Compounding Pharmacy, Augusta, GA

Clinical Specialties Compounding Pharmacy

Lack of Assurance of Sterility; product linked to adverse event reports of endophthalimitis eye infections and FDA inspection findings resulted in concerns regarding quality control processes

March 11, 2013 · DrugView details →

Class ITerminated

Night Bullet Capsules, supplied in 1 count packets, produced by Green Planet Inc, Riverside, CA

Green Planet Inc

Marketed Without an Approved NDA/ANDA; product contains analogues of sildenafil and tadalafil which are active pharmaceutical ingredients in FDA-approved drugs used to treat erectile dysfunction (ED) making this product an unapproved new drug.

March 11, 2013 · DrugView details →

Class IITerminated

LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP, 20 mg/25 mg, 100 (NDC 60429-046-01) and 1,000 (NDC 60429-046-10) count bottles, Rx only, GSMS Inc., Camarillo, CA

Gsms

Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets by the manufacturer

March 11, 2013 · DrugView details →

Class IIITerminated

4 way Saline Moisturizing Mist with Eucalyptol & Menthol, 1-fl. oz. bottles, OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.

Novartis Consumer Health

Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.

March 7, 2013 · DrugView details →

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