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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 14821–14840 of 17,832 recalls

Class IITerminated

Vitamin B12 Methylcobalamin with MIC Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial. For IM or Deep SQ Use, Multiple Dose Vial. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us

Medical Supply Liquidators Llc

Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer

June 25, 2014 · DrugView details →

Class ITerminated

Ascorbic Acid 500 mg/mL Sterile Injection, 50 mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869.

Pharmacy Creations

Non-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold contamination.

June 25, 2014 · DrugView details →

Class IITerminated

Vitamin B12 Cyanocobalamin with MIC Injection USP 1000 mcg/ml, packaged in 10 ml vials and 30 ml vials, Sterile, for IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.

Medical Supply Liquidators Llc

Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer

June 25, 2014 · DrugView details →

Class IITerminated

Vitamin B6 Pyridoxine HCL for Injection USP, 100 mg/ml, Sterile, for IM or Deep SQ Use, Multiple Dose 30 ml vial, manufactured by: CB Inc. for Sunshine Labs, www. sunshinelabs.us.

Medical Supply Liquidators Llc

Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer

June 25, 2014 · DrugView details →

Class IITerminated

Lipo 8 Injection USP 200 mg/ml, packaged in 30 ml vials, Sterile, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.

Medical Supply Liquidators Llc

Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer

June 25, 2014 · DrugView details →

Class IITerminated

Doctor's Best Red Yeast Rice 1200, 600 mg Capsules, 120-count bottle. UPC 753950001183, Manufactured for Doctor's Best San Clemente, CA 92673

Doctor's Best, Inc.

Marketed Without an Approved NDA/ANDA: FDA analysis discovered undeclared lovastatin, making this an unapproved new drug.

June 24, 2014 · DrugView details →

Class IIITerminated

Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873. Distributed by: Gavis Pharmaceuticals, LLC, Somerset, NJ 08873, NDC 43386-500-11.

Novel Laboratories, Inc.

Failed Impurity/Degradation Specification; 12-month stability time point

June 20, 2014 · DrugView details →

Class IIITerminated

Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-5445-91.

Mylan Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.

June 20, 2014 · DrugView details →

Class IITerminated

Bystolic (nebivolol) tablets, 20 mg/tablet. 7 Tablet Professional Sample Bottle, Rx Only. Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, Missouri 63045. NDC 0456-1420-07.

Forest Pharmaceuticals Inc

Failed Dissolution Specifications: Drug failed stage III dissolution testing.

June 19, 2014 · DrugView details →

Class IIITerminated

Aspirin DR Enteric Coated Tablets, USP 325 mg, UD 750 tablets (25x30), Dist. By: McKesson Packaging Services a business unit of McKesson Corporation, concord, NC

Mckesson Packaging Services

Failed Dissolution Specification; at the 12 month time interval.

June 19, 2014 · DrugView details →

Class IIITerminated

Cardura XL (doxazosin mesylate extended release tablets, 4 mg, 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., New York, NY 10017, NDC 0049-2710-30

Pfizer Inc.

Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant.

June 19, 2014 · DrugView details →

Class IIITerminated

Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05.

Mylan Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.

June 19, 2014 · DrugView details →

Class ITerminated

Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (150 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-1560-29

Hospira Inc.

Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.

June 17, 2014 · DrugView details →

Class IIITerminated

Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 0.1 mg/0.025 mg; 0.125 mg/0.025 mg; 0.15 mg/0.025 mg, 3 Dispensers x 28 Tablets, Barr Laboratories, Inc., Pomona, NY NDC 0555-9051-67

Teva Pharmaceuticals USA

Failed Impurities/Degradation Specifications: out of specification impurity test results.

June 17, 2014 · DrugView details →

Class IIITerminated

Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA. NDC 0555-9043-58

Teva Pharmaceuticals USA

Failed Impurities/Degradation Specifications: out of specification impurity test results.

June 17, 2014 · DrugView details →

Class IIITerminated

Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA NDC 0555-9050-58

Teva Pharmaceuticals USA

Failed Impurities/Degradation Specifications: out of specification impurity test results.

June 17, 2014 · DrugView details →

Class IIITerminated

Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only Teva Pharmaceuticals, USA, Sellersville, PA. NDC 51285-114-58

Teva Pharmaceuticals USA

Failed Impurities/Degradation Specifications: out of specification impurity test results.

June 17, 2014 · DrugView details →

Class IITerminated

Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500 mg/250 mL (10 mg/mL), 250 mL Single Use IntraVia container, packaged in 10 x 250 mL Single Use IntraVia containers per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1415, NDC 10019-055-61.

Baxter Healthcare Corp.

Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.

June 16, 2014 · DrugView details →

Class IITerminated

Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India. 30-Count Bottle NDC: 41616-758-83, 90-Count Bottle: NDC 41616-758-81.

Caraco Pharmaceutical Laboratories, Ltd.

Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.

June 12, 2014 · DrugView details →

Class IITerminated

Captomer-250 [succinic acid (from 250 mg DMSA)] capsules, 162 mg, 45-count bottles, Manufactured By: Thorne Research, Inc., P.O. Box 25, Dover, Idaho 83825, UPC 6 93749 73502 1

Thorne Research Inc

Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from Dimercaptosuccinic Acid (DMSA) which is the active ingredient in an FDA approved drug making these products unapproved new drugs.

June 12, 2014 · DrugView details →

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