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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 11921–11940 of 17,816 recalls

Class IIIOngoing

Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.

Hospira Inc.

Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.

March 23, 2016 · DrugView details →

8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest, IL 60045, NDC 0409-6625-02

Hospira Inc.

Presence of Particulate Matter: particulate matter identified as an insect in one vial.

March 18, 2016 · DrugView details →

Class IIITerminated

Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02

Impax Laboratories, Inc.

Labeling: Incorrect or Missing Lot and/or Exp. Date

March 17, 2016 · DrugView details →

Class IIITerminated

Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02

Impax Laboratories, Inc.

Labeling: Incorrect or Missing Lot and/or Exp. Date

March 17, 2016 · DrugView details →

Class IIITerminated

Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL Bottle, b) 5 mL Bottle, c) 10 mL Bottle, For Topical Ophthalmic Use Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701, NDC: a) 50383-0282-02, b) 50383-282-05, c) 50383-0282-10

Actavis Pharma Inc

Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-specification results for an unknown impurity at or near the expiration (24-month).

March 16, 2016 · DrugView details →

Class IIIOngoing

Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose vial, packaged in 25 Unit vials per carton, Rx only, HOSPIRA, INC., LAKE FOREST, IL 60045 USA, NDC 0409-6629-02

Hospira Inc.

Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.

March 15, 2016 · DrugView details →

Class IITerminated

Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

Meditech Laboratories, Inc

Lack of Assurance of Sterility: incomplete or missing data regarding production.

March 14, 2016 · DrugView details →

Class IITerminated

Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. .

Meditech Laboratories, Inc

Lack of Assurance of Sterility: incomplete or missing data regarding production.

March 14, 2016 · DrugView details →

Class IITerminated

Formula 9 (Papaverine 0.9 mg, Phentolamine 0.1 mg, Atropine 0.01 mg, PGE 20 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

Meditech Laboratories, Inc

Lack of Assurance of Sterility: incomplete or missing data regarding production.

March 14, 2016 · DrugView details →

Class IITerminated

Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC, Middlesex, NJ 08846, NDC 64720-0216-10

Impax Laboratories, Inc.

Failed Impurities/Degradation Specifications

March 14, 2016 · DrugView details →

Class IITerminated

Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

Meditech Laboratories, Inc

Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.

March 14, 2016 · DrugView details →

Class IITerminated

Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 08846, NDC 64720-215-10

Impax Laboratories, Inc.

Failed Impurities/Degradation Specifications

March 14, 2016 · DrugView details →

Class IITerminated

Formula 1 (Papaverine 1.8 mg, Phentolamine 0.2 mg, Atropine 0.02 mg, PGE 18 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

Meditech Laboratories, Inc

Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.

March 14, 2016 · DrugView details →

Class IITerminated

Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

Meditech Laboratories, Inc

Superpotent Drug: one ingredient was found to be above assay specification.

March 14, 2016 · DrugView details →

Class IITerminated

Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL), 5 mL vials, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

Meditech Laboratories, Inc

Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.

March 14, 2016 · DrugView details →

Class IIITerminated

Ceftriaxone for Injection USP, 2 g, Single Use Vial (NDC 68180-644-01) packaged in 10-count Vials per box (NDC 68180-644-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-633-01.

Lupin Pharmaceuticals Inc.

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

March 11, 2016 · DrugView details →

Class IIITerminated

Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-622-01), and b) 10-count Vials per box (NDC 68180-622-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.

Lupin Pharmaceuticals Inc.

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

March 11, 2016 · DrugView details →

Class IIITerminated

SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05

Jubilant Draximage Inc

Labeling: Label Error on Declared Strength

March 11, 2016 · DrugView details →

Class IIITerminated

Ceftriaxone for Injection USP, 1 g, Single Use Vial (NDC 68180-633-01) packaged in 10-count Vials per box (NDC 68180-633-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-633-01.

Lupin Pharmaceuticals Inc.

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

March 11, 2016 · DrugView details →

Class IIITerminated

Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046, (Madhya Pradesh) India; Regd. Office: 159, CST Road Kalina, Santacruz (E), Mumbai- 400 098, (Maharashtra) India.

Lupin Pharmaceuticals Inc.

CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.

March 11, 2016 · DrugView details →

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