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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 10861–10880 of 17,793 recalls

Class IITerminated

MakeSense PHARMA ANTIFUNGAL CREAM Clotrimazole 1%, 1.25 oz. (35 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-203-35

Cherry Hill Sales Co.

CGMP Deviations

January 27, 2017 · DrugView details →

Class IITerminated

MakeSense PHARMA FIRST AID CREAM Lidocaine HCL 0.5%, Phenol 0.5%, 1 oz.. (28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-210-28

Cherry Hill Sales Co.

CGMP Deviations

January 27, 2017 · DrugView details →

Class IITerminated

Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV ---NDC 51079-088-20

Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled

January 27, 2017 · DrugView details →

Class ITerminated

Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Infusion, For Intravenous Use, packaged in 100 mL glass vial, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6510-01

Hospira Inc., A Pfizer Company

Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came in contact with the reconstituted drug product.

January 24, 2017 · DrugView details →

Class IITerminated

Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV

Mylan Pharmaceuticals Inc.

Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle

January 19, 2017 · DrugView details →

Class IITerminated

glipiZIDE Extended-Release Tablets, 5 mg, 1000 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-0342-10

Mylan Pharmaceuticals Inc.

Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets

January 19, 2017 · DrugView details →

Class IITerminated

Calcipotriene Cream 0.0005%, packaged in a) 60g tube, (NDC 66993-877-61), b) 120g tube (NDC 66993-877-78), Rx Only, Manufactured by: LEO Pharma Inc., Dublin, Ireland, Manufactured for: Prasco Laboratories, Mason, OH, 45040

LEO PHARMA INC

Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the Authorized Generic labeling.

January 19, 2017 · DrugView details →

Class IITerminated

Metoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-031-50.

VistaPharm, Inc.

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

January 18, 2017 · DrugView details →

Class IITerminated

Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-039-50.

VistaPharm, Inc.

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

January 18, 2017 · DrugView details →

Class IITerminated

Lactulose Solution, USP 20 g/30 mL, 50 unit dose cups of 30 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-038-50.

VistaPharm, Inc.

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

January 18, 2017 · DrugView details →

Class IITerminated

Nystatin Oral Suspension, USP 500,000 Units/5 mL, a). 50 unit dose cups of 5 mL per case (NDC No. 66689-037-50), b). 100 unit dose cups of 5 mL per case (NDC 66689-037-99), Rx only, Manufactured by VistaPharm, Largo, FL 33771.

VistaPharm, Inc.

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

January 18, 2017 · DrugView details →

Class IITerminated

Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(120 mL), 12 bottles per case (NDC 66689-023-04), b) 16 fl.oz. (473 mL), 12 bottles per case (NDC 66689-023-16), c) 50 unit dose cups of 15 mL per case, (NDC No. 66689-023-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771

VistaPharm, Inc.

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

January 18, 2017 · DrugView details →

Class IITerminated

Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-711-16.

VistaPharm, Inc.

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

January 18, 2017 · DrugView details →

Class IITerminated

Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per case., Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-036-50.

VistaPharm, Inc.

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

January 18, 2017 · DrugView details →

Class IITerminated

Potassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL, packaged in 15 mL unit dose cups (NDC 66689-047-01), 50 unit dose cups per case (NDC 66689-047-50), Rx only, Xact Dose, Manufactured by VistaPharm, Largo, FL 33771.

VistaPharm, Inc.

Defective Container: Leakage of unit dose cups that may occur at the seal.

January 18, 2017 · DrugView details →

Class IITerminated

Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose cups of 5 mL per case (NDC No. 66689-401-50), b). 500 mL, 12 bottles per case (NDC No. 66689-403-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771.

VistaPharm, Inc.

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

January 18, 2017 · DrugView details →

Class IITerminated

Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 liter (1000 mL), 4 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-695-79.

VistaPharm, Inc.

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

January 18, 2017 · DrugView details →

Class IITerminated

Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl. oz. (30 mL), 12 bottles per case (NDC No. 66689-695-30), b). 1 liter (1000 mL), 4 bottles per case, (NDC No. 66689-695-79), Rx only, Manufactured by VistaPharm, Largo, FL 33771.

VistaPharm, Inc.

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

January 18, 2017 · DrugView details →

Class IITerminated

Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 bottles per case (NDC 66689-008-02), b) 16 fl. oz. (237 mL), 12 bottles per case (NDC 66689-008-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771

VistaPharm, Inc.

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

January 18, 2017 · DrugView details →

Class IIITerminated

Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension, 0.005%/0.064%, packaged in (a) 60 g (NDC 50222-501-06), and (b)120 g (50222-501-66) tubes, Rx Only, Manufactured by: LEO Laboratories Ltd., 285 Cashel Road, Dublin 12 Ireland, Distributed by: LEO Pharma Inc. 1 Sylvan Way, Parsippany, NJ 07054.

LEO PHARMA INC

Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.

January 16, 2017 · DrugView details →

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