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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 16321–16340 of 17,860 recalls

Class IITerminated

Parsel Plus (reference US product: Excedrin Tension Headache) (Acetaminophen 500 mg and Caffeine 65 mg), packaged in 2-count pouches, Distributed by Novartis Consumer Health, Inc., USA and Novartis Consumer Health S.A., Brazil, for Novartis de Venezuela. The foreign packaging do not have NDC number This product was only distributed to Novartis Brazil by the recalling firm

Novartis Consumer Health

Defective container: products are packaged in pouches which may not have been fully sealed

June 6, 2013 · DrugView details →
Class IITerminated

0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-02

Hospira Inc.

Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container.

June 6, 2013 · Drug
View details →
Class IITerminated

No Doz, Max Strength (200 mg caffeine) caplets, 2-count caplets per pouch, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 2070 02

Novartis Consumer Health

Defective container: products are packaged in pouches which may not have been fully sealed

June 6, 2013 · DrugView details →
Class IITerminated

Excedrin Extra Strength (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-ct tablets in pouches b) boxes of 50/2-ct packages, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 2030 02 Foreign packaging: c) Parsel Forte and d) Cibalenaa (250 mg Acetaminophen, 250 mg Aspirin, 65 mg Caffeine), boxes of 48/4-ct pouches Foreign packaging do not have NDC numbers.

Novartis Consumer Health

Defective container: products are packaged in pouches which may not have been fully sealed

June 6, 2013 · DrugView details →
Class IITerminated

Cleocin Phosphate (clindamycin Injection), USP, a) 600 mg/4mL (150 mg/mL) ADD-Vantage Vial, b) 900 mg/6mL (150 mg/mL) ADD-Vantage Vial, Rx Only, For Intravenous Use Only, Use Only with the ADD-Vantage diluent container, Distributed by Pharmacia & Upjohn Co, Division of Pfizer Inc, NY, NY 10017, NDC a) 0009-3124-03 and b) 0009-3447-03

Pharmacia & Upjohn LLC

Presence of Particulate Matter: Firm is recalling a small number of vials with very small reflective flakes consistent with delamination of the glass vial.

June 4, 2013 · DrugView details →
Class IITerminated

VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx Only, Mfd. for VersaPharm Incorporated Marietta, GA 30065-1509; Mfd. by: West-ward Pharmaceuticals Corp., Eatontown, NJ 07724 NDC 61748-014-06,

West-Ward Pharmaceutical Corp.

Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification result for description testing for a surface defect of ink.

June 4, 2013 · DrugView details →
Class IIITerminated

Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in 5-count systems per box (NDC 0591-3212-72), Rx only, Manufactured by Watson Laboratories, Inc, Corona, CA, 92880 USA; Distributed by: Watson Pharma, Inc.

Actavis

Failed Impurities/Degradation Specifications

June 3, 2013 · DrugView details →
Class IIITerminated

Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/2.5 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA, NDC 0046-0875-11

Pfizer Inc.

Failed Dissolution Specifications: Pfizer Inc. is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the dissolution specification for conjugated estrogens.

May 31, 2013 · DrugView details →
Class IIITerminated

Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/5.0 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA 1910, NDC 0046-0975-11

Pfizer Inc.

Failed Dissolution Specifications: Pfizer Inc. (Pfizer) is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the specification for conjugated estrogens dissolution.

May 31, 2013 · DrugView details →
Class ITerminated

Calcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 ml vial, Rx only, Abrams Royal Compounding Pharmacy, 8220 Abrams Rd, Dallas, TX 75231.

Abrams Royal Pharmacy

Non-Sterility: The firm's contract testing laboratory found sterility failures.

May 31, 2013 · DrugView details →
Class IIITerminated

Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31), and b) 500-count bottles (NDC 0025-2742-51), Rx only, Distributed by G.D. Searle LLC, Division of Pfizer Inc, NY, NY 10017.

Pfizer Inc

Failed Dissolution Specification

May 31, 2013 · DrugView details →
Class IITerminated

Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, single-use vial, Manufactured in Austria by Sandoz GmbH for Sandoz, Inc. Princeton, NJ 08540, NDC 00781-3451-70 (vial), NDC 00781-3451-96 (box)

Sandoz Incorporated

Lack of Assurance of Sterility: Sandoz Inc is recalling Cefazolin for Injection, USP 1 gm vials, lot DB2208, due to a customer complaint for broken/cracked vials which was confirmed through review of retained samples.

May 30, 2013 · DrugView details →
Class IIITerminated

Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection for Mycardial and Breast Imaging. For Intravenous Use and Reconstitution. a) Five vials kits: NDC# 45567-0555-1, b) Thirty vials kits: NDC# 45567-0555-2, Rx Only, Manufactured by: Pharmalucence, Inc., Billerica, MA 01821

Pharmalucence, Inc.

Presence of Particulate Matter; particulate found in retain samples

May 30, 2013 · DrugView details →
Class IIOngoing

Diclazuril 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL

Lowlite Investments, Inc. D/B/A Olympia Pharmacy

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

May 29, 2013 · DrugView details →
Class IIOngoing

Ketamine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL

Lowlite Investments, Inc. D/B/A Olympia Pharmacy

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

May 29, 2013 · DrugView details →
Class IIOngoing

Metabolase Injection, compounded by Olympia Pharmacy, Orlando, FL

Lowlite Investments, Inc. D/B/A Olympia Pharmacy

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

May 29, 2013 · DrugView details →
Class IIOngoing

Acetyl-D-Glucosamine w/Chondroitin 200 mg/ml, compounded by Olympia Pharmacy, Orlando, FL

Lowlite Investments, Inc. D/B/A Olympia Pharmacy

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

May 29, 2013 · DrugView details →
Class IIOngoing

Dexpanthenol 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL

Lowlite Investments, Inc. D/B/A Olympia Pharmacy

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

May 29, 2013 · DrugView details →
Class IIOngoing

Atropine Sulfate 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL

Lowlite Investments, Inc. D/B/A Olympia Pharmacy

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

May 29, 2013 · DrugView details →
Class IIOngoing

Glutathione 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL

Lowlite Investments, Inc. D/B/A Olympia Pharmacy

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

May 29, 2013 · DrugView details →
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