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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 421–440 of 1,000 recalls

Class IIITerminated

Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 25 (2 mL multi-dose vial) per carton, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA; Manufactured by: Mylan Institutional, Galway, Ireland. NDC: 67457-196-02

Mylan Institutional LLC

Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number 200901.

May 3, 2021 · DrugView details →

Class IIITerminated

Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem Laboratories Ltd, Mumbai, 400 013. INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054, NDC 67877-446-30.

Ascend Laboratories LLC

Presence of Foreign Tablet/Capsule

April 29, 2021 · DrugView details →

Class IIITerminated

DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, Waltham, MA 02451, NDC 49230-0212-50

Fresenius Medical Care Holdings, Inc.

Temperature Abuse: Product exposed to temperature outside specified limits.

April 28, 2021 · DrugView details →

Class IIITerminated

DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL, packs of 5, Rx only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-212-92

Fresenius Medical Care Holdings, Inc.

Temperature Abuse: Product exposed to temperature outside specified limits.

April 28, 2021 · DrugView details →

Class IIITerminated

DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDC 49230-0209-23), b) 3000 mL (NDC 49230-209-30) and c) 5000 mL (NDC 49230-209-50) Rx only, Fresenius Medical Care NA Waltham, MA 02451

Fresenius Medical Care Holdings, Inc.

Temperature Abuse: Product exposed to temperature outside specified limits.

April 28, 2021 · DrugView details →

Class IIITerminated

DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, packaged in a) 2500 mL (NDC 49230-209-94) and b) 2000mL, packs of 5 (NDC 49230-209-92) Fresenius Medical Care NA, Waltham, MA 02451,

Fresenius Medical Care Holdings, Inc.

Temperature Abuse: Product exposed to temperature outside specified limits.

April 28, 2021 · DrugView details →

Class IIITerminated

DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49230-206-30) and b) 5000mL bags, 2 packs (NDC 49230-206-50), Rx only, Fresenius Medical Care NA, Waltham, MA 02451

Fresenius Medical Care Holdings, Inc.

Temperature Abuse: Product exposed to temperature outside specified limits.

April 28, 2021 · DrugView details →

Class IIITerminated

DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-206-92

Fresenius Medical Care Holdings, Inc.

Temperature Abuse: Product exposed to temperature outside specified limits.

April 28, 2021 · DrugView details →

Class IIITerminated

DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-50

Fresenius Medical Care Holdings, Inc.

Temperature Abuse: Product exposed to temperature outside specified limits.

April 28, 2021 · DrugView details →

Class IIITerminated

Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd. By:KVK-Tech, Inc., Newtown, PA, 18940 NDC 10702-055-03

KVK-Tech, Inc.

Failed Impurities/Degradation Specifications

April 27, 2021 · DrugView details →

Class IIITerminated

Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-227-01. Packaged in 150 cc white HDPE bottle

Heritage Pharmaceuticals Inc

Labeling: Incorrect or Missing Lot and/or Exp Date

April 21, 2021 · DrugView details →

Class IIITerminated

Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution, Rx only, Distributed by: Genentech, Inc. NDC:50242-175-05

Genentech Inc

Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so they cannot be used in combination with co-packed syringes.

April 20, 2021 · DrugView details →

Class IIITerminated

Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10.

SigmaPharm Laboratories LLC

Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent

April 19, 2021 · DrugView details →

Class IIITerminated

Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10

SigmaPharm Laboratories LLC

Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent

April 19, 2021 · DrugView details →

Class IIITerminated

Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips USP (0.12mg Fluorescein Sodium), 100 Sterile Strips (50 Pouches of 2 Strips Each), Manufactured by: Nomax, Inc, St. Louis, MO 63123, NDC: 51801-008-15

Nomax Inc

Subpotent Drug

April 13, 2021 · DrugView details →

Class IIITerminated

Lidocaine Ointment USP, 5%, NET WT 35.44 g (1 1/4 Oz) tube, Rx Only, Teligent Pharma Inc., Buena, New Jersey, 08310, NDC 52565-008-14.

Teligent Pharma, Inc.

Failed Stability Specifications: product did not meet viscosity results.

March 29, 2021 · DrugView details →

Class IIITerminated

Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda HIghway, Halol-389 350 Gujarat, India, NDC 62756-142-02.

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Moisture Limits: Out of specification for water content

March 25, 2021 · DrugView details →

Class IIITerminated

Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Daman (U.T.), India, NDC 33342-114-10

Macleods Pharma Usa Inc

Failed Impurities/Degradation Specifications

March 22, 2021 · DrugView details →

Class IIIOngoing

Distributed by: DocRx, Methylprednisolone Tablets, USP 4 mg, Rx, 21 Count Blister, NDC: 69306-004-21, Relabeled by: Enovachem Pharmaceuticals 379 Van Ness Ave. Suite 1403-1406, Torrance, CA 90501, Manufactured by: Jubilant Cadista Pharmaceuticals Inc. Source NDC: 59746-001-03, DocRx, Mobile, AL 36608

Asclemed USA Inc. dba Enovachem Pharmaceuticals

Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed dosing instructions on the blister card.

March 19, 2021 · DrugView details →

Class IIITerminated

Sp-4, 100 mL solution bottles, Rx only, Washington Homeopathic Products, Inc.260 J R Hawvermale Way Berkeley Springs West Virginia 25411

Washington Homeopathic Products, Inc.

An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.

March 18, 2021 · DrugView details →

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