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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 17401–17420 of 17,860 recalls

Class IITerminated

Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/mL P Injection, manufactured by New England Compounding Center, Framingham, MA

New England Compounding Center

Lack of Assurance of Sterility

September 26, 2012 · DrugView details →

Class IITerminated

Betamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Phosphate 6 mg/mL PF Injection, Betamethasone Sodium Phosphate 8 mg/mL PF Injection, Betamethasone Sodium Phosphate 12 mg/mL PF Injection, manufactured by New England Compounding Center, Framingham, MA

New England Compounding Center

Lack of Assurance of Sterility

September 26, 2012 · DrugView details →

Class IITerminated

Bupivacaine 0.25% PF, Bupivacaine 0.5% PF, and Bupivacaine 0.75% PF, manufactured by New England Compounding Center, Framingham, MA

New England Compounding Center

Lack of Assurance of Sterility

September 26, 2012 · DrugView details →

Class ITerminated

Methylprednisolone Acetate (PF) 80 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA

New England Compounding Center

Non-Sterility

September 26, 2012 · DrugView details →

Class IITerminated

Clonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Compounding Center, Framingham, MA

New England Compounding Center

Lack of Assurance of Sterility

September 26, 2012 · DrugView details →

Class IITerminated

Lidocaine/Dextrose 5%/7.5% PF, manufactured by New England Compounding Center, Framingham, MA

New England Compounding Center

Lack of Assurance of Sterility

September 26, 2012 · DrugView details →

Class ITerminated

Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

New England Compounding Center

Non-Sterility

September 26, 2012 · DrugView details →

Class IITerminated

Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL PF vials, manufactured by New England Compounding Center, Framingham, MA

New England Compounding Center

Lack of Assurance of Sterility

September 26, 2012 · DrugView details →

Class IITerminated

Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

New England Compounding Center

Lack of Assurance of Sterility

September 26, 2012 · DrugView details →

Class ITerminated

Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 00591-0540-05.

Watson Laboratories Inc

Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.

September 21, 2012 · DrugView details →

Class IITerminated

10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0163, NDC 0338-6347-03

Baxter Healthcare Corp.

Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).

September 21, 2012 · DrugView details →

Class IITerminated

Lactated Ringer's Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E2322B, NDC 0338-6307-02; b) 500 mL AVIVA Container, product code 6E2323, NDC 0338-6307-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA

Baxter Healthcare Corp.

Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).

September 21, 2012 · DrugView details →

Class IITerminated

Limed Bone Gelatin, packaged in six 125 kg fiber drums and labeled in part PO NO.: P8095 GELATIN 75 BLOOM ITEM NO. RM 164. MADE IN INDIA

American Enterprises LLC dba Sterling Gelatin

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

September 21, 2012 · DrugView details →

Class IITerminated

5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E0062, NDC 0338-6346-02; b) 500 mL AVIVA Container, product code 6E0063, NDC 0338-6346-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA

Baxter Healthcare Corp.

Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).

September 21, 2012 · DrugView details →

Class IITerminated

5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0173, NDC 0338-6308-03

Baxter Healthcare Corp.

Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).

September 21, 2012 · DrugView details →

Class IITerminated

0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E1322, NDC 0338-6304-02; b) 500 mL AVIVA Container, product code 6E1323, NDC 0338-6304-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA

Baxter Healthcare Corp.

Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).

September 21, 2012 · DrugView details →

Class ITerminated

SLIM XTREME Herbal Slimming Capsule, supplied in 30-count bottles. Another Product Forumulated and Distributed By: Globe All Wellness, LLC Hollywood, FL 33020 www.diet66.com Inquires Call 877.842.9873

Globe All Wellness, LLC

Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.

September 20, 2012 · DrugView details →

Class IITerminated

Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0076-01

Genentech Inc

Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20 reporting that the dose knob spun slowly and the injection took longer than usual (slow dose delivery).

September 20, 2012 · DrugView details →

Class IITerminated

Nutropin AQ NuSpin 10 (somatropin (rDNA origin) injection} 10 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0074-01

Genentech Inc

Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20 reporting that the dose knob spun slowly and the injection took longer than usual (slow dose delivery).

September 20, 2012 · DrugView details →

Class IIITerminated

Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ NDC 0781-5283-64 --- ALSO sold under Major brand All Day Allergy Children's Cetirizine HCl 5 mg, 5 count blister pack, Major Pharmaceuticals, Livonia, MI NDC 0904-5878-33

Sandoz Incorporated

Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)

September 20, 2012 · DrugView details →

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