FDA Drug Recalls

1,709 recalls · Class III, newest first

Class III · Low risk Terminated Mar 26, 2015

Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100 tablets (10 X 10) per UD Cartons…

Reason Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound…

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) NDC 51079-547-20 D-1083-2015

Class III · Low risk Terminated Mar 26, 2015

Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day Dosage, 300 mg, 90-count bottles, Rx only, Manufactured by…

Reason Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of the capsule shell

Actavis Laboratories, FL, Inc. NDC 62037-0600-90 D-0488-2015

Class III · Low risk Terminated Mar 25, 2015

PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10 mg, Promethazine Hydrochloride 6.25 mg…

Reason Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room…

Qualitest Pharmaceuticals NDC 0603-1588-54 D00432-2015

Class III · Low risk Terminated Mar 24, 2015

Fluorescein Sodium Ophthalmic Strips USP, 1.0 mg per strip, labeled as 1) FUL-GLO, individually wrapped strips, barcode…

Reason Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to…

Nomax Inc NDC 17478-404-01 D-0963-2015

Class III · Low risk Terminated Mar 24, 2015

Rose Bengal GloStrips (rose bengal) Ophthalmic Strips USP, 1.3 mg per strip, individually wrapped strip (NDC 51801-004-01)…

Reason Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to…

Nomax Inc NDC 51801-004-01 D-0962-2015

Class III · Low risk Terminated Mar 24, 2015

Fluorescein Sodium Ophthalmic Strips USP, 0.6 mg per strip, labeled as 1) Fluorescein GloStrips, individually wrapped strip (NDC…

Reason Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to…

Nomax Inc NDC 51801-003-01 D-0961-2015

Class III · Low risk Terminated Mar 11, 2015

Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allergies, Non-Drowsy, Original Prescription…

Reason Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.

Mylan Pharmaceuticals Inc. NDC 0378-0781-91 D-0435-2015

Class III · Low risk Terminated Mar 10, 2015

AIR COMPRESSED, Medical Air, USP, Rx Only. Matheson Tri-Gas, Inc., 150 Allen Road, Basking Ridge, NJ 07920. Available in A) E…

Reason Failed Impurities/Degradation Specification; out of specification results for carbon dioxide

Matheson, Inc. D-0423-2015

Class III · Low risk Terminated Feb 27, 2015

Quinapril Tablets USP, 40 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478…

Reason Subpotent Drug

AVKARE Inc. NDC 50268-691-15 D-0402-2015

Class III · Low risk Terminated Feb 27, 2015

Quinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC…

Reason Subpotent Drug

AVKARE Inc. NDC 50268-688-15 D-0401-2015

Class III · Low risk Terminated Feb 26, 2015

Oxecta(TM) (oxycodone HCl) tablets, 7.5 mg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals…

Reason Failed Impurities/Degradation Specifications

Pfizer Inc. NDC 60793-526-01 D-0404-2015

Class III · Low risk Terminated Feb 26, 2015

Oxecta(TM) (oxycodone HCl) tablets, 5 mg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals…

Reason Failed Impurities/Degradation Specifications

Pfizer Inc. NDC 60793-525-01 D-0403-2015

Class III · Low risk Terminated Feb 16, 2015

Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5 mL Single Dose Vials, For Intravenous or…

Reason Failed Impurities/Degradation Specifications; 12 month stability testing.

West-Ward Pharmaceutical Corporation NDC 0641-6028-25 D-0420-2015

Class III · Low risk Terminated Feb 12, 2015

Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, FL, 33326. Available in a) 1.7 mL Bottle, NDC…

Reason CGMP Deviations: Product excipient was not re-tested at the appropriate date.

Apotex Inc. D-0487-2015

Class III · Low risk Terminated Feb 12, 2015

Z-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane, powder, Net: 22 kg, Packaged in double plastic…

Reason Labeling: Illegible label. Writing is rubbing off of labels.

Nanophase Technologies Corporation D-0400-2015

Class III · Low risk Terminated Feb 11, 2015

DOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 mg/mL), For IV Use Only, Sterile, ISOTONIC SOLUTION, Caution…

Reason Correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may have been mis-packaged in a carton labeled…

Mylan Institutional LLC NDC 53150-317-01 D-0412-2015

Class III · Low risk Terminated Jan 23, 2015

Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for: Mylan…

Reason Subpotent Drug and Failed Impurities/Degradation Specifications

Mylan Institutional LLC NDC 67457-224-10 D-0413-2015

Class III · Low risk Terminated Jan 8, 2015

5-methyltetrahydrofolate Calcium (L) (a) 1 gm in 2 oz container NDC: 52372-0855-04; (b) 5 gm in 2 oz container NDC…

Reason Subpotent Drug

Freedom Pharmaceuticals Inc D-0562-2016

Class III · Low risk Terminated Dec 26, 2014

Deferoxamine various strengths in normal saline

Reason Lack of sterility assurance.

Walgreens Infusion Services D-0370-2015

Class III · Low risk Terminated Dec 22, 2014

ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles, NDC…

Reason Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.

Qualitest Pharmaceuticals NDC 0603-9013-54 D-0331-2015

Class III · Low risk Terminated Dec 19, 2014

3M ESPE Clinpro 5000 (1.1% Sodium Flouride), Anti-Cavity Toothpaste, 4 oz tube (NDC 48878-3130-04), Rx Only, Manufactured for 3M…

Reason Labeling: Incorrect or Missing Lot and/or Exp. Date - The subject lot is missing the lot number and expiration date stamp on the primary box..

3M Company/3m Espe Dental Products NDC 48878-3130-04 D-0376-2015

Class III · Low risk Terminated Dec 9, 2014

Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60).

Reason Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point.

Akorn, Inc. NDC 61748-219-60 D-0333-2015

Class III · Low risk Terminated Dec 9, 2014

sulfur8(R) medicated anti-dandruff conditioner, dandruff treatment for Braids, spray, Active Ingredient: Salicylic Acid, 2%, 12…

Reason Failed pH specification: Product pH test value of 5.72 failed to meet its product specification of 6.0 to 7.5.

J. Strickland and Co D-0318-2015

Class III · Low risk Terminated Dec 5, 2014

BELVIQ¿ (Lorcaserin HCl) Tablets, 10 mg, 60-count bottle, Rx only, Manufactured by: Arena Pharmaceuticals, GmbH, Zofingen…

Reason Labeling:Missing Label: Bottles may not have a product label, or have a label with missing or illegible lot number and/or expiry date.

Eisai Inc D-0302-2015

Class III · Low risk Terminated Dec 5, 2014

Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01

Reason Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.

Sandoz Incorporated NDC 0781-2822-01 D-0291-2015