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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 461–480 of 1,000 recalls

Class IIITerminated

Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus Lifesciences Inc. NDC 64950-354-05 Case NDC: 64950-354-450(40 unit dose cups) Case NDC 64950-354-55 (50 unit dose cups)

Genus Lifesciences Inc.

Presence of Foreign Substance: Particulate matter was found in multiple lots of product.

December 23, 2020 · DrugView details →

Class IIITerminated

NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816

Strides Pharma Inc.

Failed Moisture Limits

December 22, 2020 · DrugView details →

Class IIITerminated

Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe, Single Use Syringe, 0.025%/0.75%, Rx only, Edge Pharma LLC 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0863-01

Edge Pharma, LLC

Labeling: Incorrect or Missing Lot and/or Exp Date

December 22, 2020 · DrugView details →

Class IIITerminated

Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc., Newtown, PA 18940 USA, NDC 10702-344-01

KVK-Tech, Inc.

Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A

December 18, 2020 · DrugView details →

Class IIITerminated

Morphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride (1mg/mL) CII, Rx Only, 3 ml Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010025

SCA Pharmaceuticals

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

December 17, 2020 · DrugView details →

Class IIITerminated

Succinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes, Rx only, US Compounding, 1270 Don's Lane, Conway, AR 72032

US Compounding Inc

Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in the incorrect position on the product label making it illegible.

December 16, 2020 · DrugView details →

Class IIITerminated

Neostigmine Methylsulfate PF Inj. 5 mg/5 mL, 5 mL Single Use Syringes, Hospital/Office Use Only. US Compounding 1270 Don's Lane Conway, AR 72032 (800) 718-3588 NDC 62295-3324-05

US Compounding Inc

Labelling: Missing label.

November 25, 2020 · DrugView details →

Class IIITerminated

Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), packaged in cartons of 50 cartridges (1.7 mL each), Rx only, Manufactured for SEPTODONT, Inc., Louisville, CO 80027, by Novocol Pharmaceutical of Canada, Inc., Cambridge, ON N1R 6X3, Canada, NDC 0362-1098-90

Novocol Pharmaceutical of Canada, Inc.

Labeling: Label mix-up

November 20, 2020 · DrugView details →

Class IIITerminated

Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205

SCA Pharmaceuticals

Subpotency: Out-of-specification stability test result for low potency was obtained.

November 20, 2020 · DrugView details →

Class IIITerminated

DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL vial, Single Dose Vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047. NDC: 63323-883-05

Fresenius Kabi USA, LLC

Cross Contamination with Other Products: trace amounts of octreotide found during testing

November 17, 2020 · DrugView details →

Class IIITerminated

Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Unit-Dose Packets per carton (NDC 0591-3216-30), Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054.

Teva Pharmaceuticals USA

Superpotent Drug: High out-of-specification assay results were obtained during stability testing.

November 11, 2020 · DrugView details →

Class IIITerminated

Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex Pharmceuticals, Inc. New Castle, DE 19720. NDC 10135-0639-30

InvaTech Pharma Solutions, LLC

Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.

November 11, 2020 · DrugView details →

Class IIITerminated

Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent Pharma. Inc. Buena, NJ 08310 NDC 52565-039-60

Teligent Pharma, Inc.

Superpotent and Subpotent; low and high assay results

November 5, 2020 · DrugView details →

Class IIITerminated

Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-010-59

Teligent Pharma, Inc.

Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results.

November 3, 2020 · DrugView details →

Class IIITerminated

Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) blister pack, Rx only, Manufactured by: Jubilant Generics, Ltd., Roorkee, India, Marketed by: Jubilant Cardista Pharmaceuticals, Inc., Salisbury, MD NDC 59746-0306-32

Jubilant Cadista Pharmaceuticals, Inc.

Subpotent

October 26, 2020 · DrugView details →

Class IIITerminated

Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc. East Brunswick, NJ 08816 Made in India, NDC 23155-050-01

Heritage Pharmaceuticals Inc

Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A

October 23, 2020 · DrugView details →

Class IIITerminated

Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer, 4 fl oz (120 mL), Berry Flavor, Distributed by Chalkboard Health Inc. Princeton, NJ 08540 getfluenthealth.com Made in India. NDC 79395-003-92

Aurobindo Pharma USA Inc.

Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.

October 22, 2020 · DrugView details →

Class IIITerminated

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 25 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-281-10

ANI Pharmaceuticals, Inc.

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

October 9, 2020 · DrugView details →

Class IIITerminated

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 20 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-280-10

ANI Pharmaceuticals, Inc.

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

October 9, 2020 · DrugView details →

Class IIITerminated

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 30 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-282-10

ANI Pharmaceuticals, Inc.

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

October 9, 2020 · DrugView details →

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