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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 11241–11260 of 17,816 recalls

Class IITerminated

Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal Injection, 1 mL Total Volume in a 2 mL Vial, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-003-35

Leiter's Compounding

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

September 20, 2016 · DrugView details →

Class IITerminated

Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-007-35

Leiter's Compounding

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

September 20, 2016 · DrugView details →

Class IITerminated

Vancomycin 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35

Leiter's Compounding

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

September 20, 2016 · DrugView details →

Class IITerminated

Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-002-35

Leiter's Compounding

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

September 20, 2016 · DrugView details →

Class IITerminated

Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35

Leiter's Compounding

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

September 20, 2016 · DrugView details →

Class IITerminated

Testosterone 200 mg/Anastrozole 9 mg Pellet, Compounded by: Wells Pharmacy Network

Wells Pharmacy Network, LLC

Superpotent and Subpotent drugs

September 19, 2016 · DrugView details →

Class IIITerminated

Testosterone Cholesterol ,100 mg Pellet, Compounded by: Wells Pharmacy Network

Wells Pharmacy Network, LLC

Superpotent and Subpotent drugs

September 19, 2016 · DrugView details →

Class IIITerminated

Testosterone 12.5 mg Pellet, Compounded by: Wells Pharmacy Network

Wells Pharmacy Network, LLC

Superpotent and Subpotent drugs

September 19, 2016 · DrugView details →

Class IITerminated

Testosterone 200 mg/Anastrazole 20mg Pellet, Compounded by: Wells Pharmacy Network

Wells Pharmacy Network, LLC

Superpotent and Subpotent drugs

September 19, 2016 · DrugView details →

Class IIITerminated

Estradiol 12.5 mg Pellet, Compounded by: Wells Pharmacy Network

Wells Pharmacy Network, LLC

Superpotent and Subpotent drugs

September 19, 2016 · DrugView details →

Class IIITerminated

Estradiol 3 mg Pellet, Compounded by: Wells Pharmacy Network

Wells Pharmacy Network, LLC

Superpotent and Subpotent drugs

September 19, 2016 · DrugView details →

Class IITerminated

Testosterone 60 mg/Anastrazole 4 mg Pellet, Compounded by: Wells Pharmacy Network

Wells Pharmacy Network, LLC

Superpotent and Subpotent drugs

September 19, 2016 · DrugView details →

Class IITerminated

Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1587-50.

Hospira Inc., A Pfizer Company

Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.

September 16, 2016 · DrugView details →

Class IITerminated

Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1610-50.

Hospira Inc., A Pfizer Company

Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.

September 16, 2016 · DrugView details →

Class IIITerminated

Xanax (Alprazolam) USP, CIV, 0.5 mg tablets , 10 x 10 blister cards per carton, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08805, NDC 63739-669-10

Mckesson Packaging Services

Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no product information (e.g. product name, strength, lot number, expiry).

September 15, 2016 · DrugView details →

Class IIITerminated

PREMARIN (conjugated estrogen tablets, USP) 1.25 mg, 1000- count bottle, Rx only, Distributed by: Wyeth Pharmaceuticals Inc. A subsidiary of Pfizer Inc. Philadelphia, PA 19101, NDC 0046-1104-91

Pfizer Inc.

Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11/17; the correct date is 09/17.

September 15, 2016 · DrugView details →

Class IITerminated

Desoximetasone Cream USP, 0.25% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1270-7

Taro Pharmaceuticals, Inc.

Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).

September 13, 2016 · DrugView details →

Class IITerminated

Desoximetasone Cream USP, 0.05% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1271-7

Taro Pharmaceuticals, Inc.

Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).

September 13, 2016 · DrugView details →

Class IIITerminated

buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by Sun Pharmaceuticals Ind. Ltd. Halol- Baroda Highway, Halol-389 350, Gujarat, India. UPC 347335737868 NDC 47335-737-86

Sun Pharmaceutical Industries, Inc.

Failed Dissolution Specifications

September 13, 2016 · DrugView details →

Class IIITerminated

mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01.

Teva Pharmaceuticals USA

Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.

September 13, 2016 · DrugView details →

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