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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 9801–9820 of 17,793 recalls

Class IITerminated

Dry to Normal Skin Starter Kit, Trousse debutante pour peau seche a normale. Kit includes: (Vegetable Cleanser (60 ml / 2 oz), Night Cream (15 g / 0.5 oz), Day Cream SPF15 {Octinoxate 7%, Avobenzone 2% and Oxybenzone 5%} (15 g / 0.5 oz), Eye Cream (6 g / 0.21 oz).Made in Canada, Kamins Dermatologics Inc. Montreal, Quebec H9R 2Y6. Distributed by Kamins Dermatologics (USA) Inc. 99 Hudson, New York, NY, USA. UPC code 6 06354 61322 4

Odan Laboratories Ltd

Failed Stability Specifications:stability failure at 12 months, long term RT conditions.

December 20, 2017 · DrugView details →

Class IITerminated

Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories Ltd. Ind. Area, Meerut Road, Ghaziabad-201 003, India. Marketed By: Unichem Pharmaceuticals (USA), Inc. Hasbrouck Heights, NJ 07604. NDC 29300-140-01

Unichem Pharmaceuticals Usa Inc

Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.

December 19, 2017 · DrugView details →

Class IIITerminated

Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-707-10

Osmotica Pharmaceutical Corp

Subpotent Drug

December 18, 2017 · DrugView details →

Class IIITerminated

Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-709-10

Osmotica Pharmaceutical Corp

Subpotent Drug

December 18, 2017 · DrugView details →

Class IITerminated

0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-2304-10

B. Braun Medical Inc

Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap

December 15, 2017 · DrugView details →

Class IIITerminated

Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only. Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701. NDC: 50383-311-47

Akorn Inc

CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.

December 15, 2017 · DrugView details →

Class IITerminated

Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1

Amneal Pharmaceuticals

Presence of particulate matter

December 15, 2017 · DrugView details →

Class IITerminated

Shiseido Future Solution LX Universal Defense SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in a) 2mL, b) 15 mL and c) 50 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022. NDC 58411-256-60

SHISEIDO AMERICA INC.

GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.

December 14, 2017 · DrugView details →

Class IITerminated

Shiseido Future Solution LX Discovery Set contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022,

SHISEIDO AMERICA INC.

GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.

December 14, 2017 · DrugView details →

Class IITerminated

SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx Only, Made in Germany, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0075-47

Boehringer Ingelheim Pharmaceuticals, Inc.

Failed Stability Specifications

December 14, 2017 · DrugView details →

Class IITerminated

Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg, 100-count bottle, Rx only, Distributed By: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5213-01.

Teva Pharmaceuticals USA

Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was obtained during routine stability testing.

December 14, 2017 · DrugView details →

Class IITerminated

bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (zinc oxide 23.8%, titanium dioxide 4.1%), 40 mL/1.35 fl. oz. bottle, Dist. by Bare Escentuals Beauty, Inc. SF, CA 94105 USA, NDC 98132-761-01

SHISEIDO AMERICA INC.

GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.

December 14, 2017 · DrugView details →

Class IITerminated

Shiseido Future Solution LX Luxurious Eye & Lip Collection contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022

SHISEIDO AMERICA INC.

GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.

December 14, 2017 · DrugView details →

Class IITerminated

Shiseido Future Solutions LX Triple Points Bonus contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022, NDC 58411-256-60

SHISEIDO AMERICA INC.

GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.

December 14, 2017 · DrugView details →

Class IITerminated

INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx Only, packaged in a) single dose vials, (NDC 52544-931-07), b) carton of 10 x 2 ml Single Dose Vials (NDC 52544-931-02) Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, Manufactured by: Patheon Italia S.p.A. Ferentino, Italy 03013.

ALLERGAN

Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.

December 13, 2017 · DrugView details →

Class IIITerminated

Auryxia (ferric citrate) tablets, 210 mg , 200-count bottles, RX ONLY, Manufactured for and distributed by: Keryx Biopharmaceticals, Inc. One Marina Park Drive, 12th Floor, Boston, MA 02210 USA. NDC 59922-631-01

Keryx Biopharmaceuticals, Inc.

Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets in the bottle.

December 12, 2017 · DrugView details →

Class IITerminated

Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant ,16 fl. oz. , Manufactured For: Method Pharmaceuticals, LLC Arlington, TX 76006, NDC 58657-500-16

Woodfield Pharmaceutical, LLC

Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia

December 12, 2017 · DrugView details →

Class ITerminated

BodySlim Herbal Advanced technology & Strong formula capsules, 400 mg, 30-count bottle, Barcode: 9567153432481

BotanicalNow

Marketed without an approved NDA/ANDA: FDA analysis found the product to contain undeclared sibutramine.

December 7, 2017 · DrugView details →

Class IITerminated

Neutrogena deep clean purifying whipped foam cleanser, (Salicylic Acid 0.5%), aerosolized product in a can, NET WT. 5 OZ. (141 g) Distributed By: Johnson & Johnson Consumer Inc. Skillman, NJ 08558. UPC: 0 70501 10053 0

Johnson & Johnson

Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.

December 7, 2017 · DrugView details →

Class IITerminated

Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe, Total Volume 10 mL, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0600-12

SCA Pharmaceuticals

Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and beyond use date.

December 7, 2017 · DrugView details →

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