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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 2201–2220 of 17,711 recalls

Class IICompleted

ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple-Dose Vial, RX ONLY, Compounded by: Empower Pharmacy, 5980 W Sam Houston Pkwy N Ste 300 Houston, TX 77041, NDC 72627-2405-1

Empower Clinic Services LLC dba Empower Pharmacy

Mislabeling: preservative free product labeled as preserved.

May 12, 2023 · DrugView details →
Class IITerminated

Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25), Rx only, Manufactured by West-Ward, Eatontown, NJ 07724.

Hikma Pharmaceuticals USA Inc.

Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.

May 11, 2023 · DrugView details →
Class IIOngoing

Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use Only, Compounded Drug Product By: Revive Rx, 3831 Golf Dr A, Houston, TX 77018, NDC: 99000-9278-64.

Revive Rx LLC dba Revive Rx Pharmacy

Sub-potent Drug

May 11, 2023 · DrugView details →
Class IITerminated

Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B. Braun Medical Inc. Bethlehem, PA 18018, USA; API from Spain NDC: 0264-9587-20,

B. Braun Medical Inc

Subpotent: Low anti-factor IIa Potency.

May 9, 2023 · DrugView details →
Class IIOngoing

HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0600-2

SSM Health Care St. Louis DBA SSM St. Clare Health Center

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

May 9, 2023 · DrugView details →
Class IITerminated

buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Dissolution Specifications; during stability testing

May 9, 2023 · DrugView details →
Class IIITerminated

Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injection Only, Not for Intravenous Use, 1 mL Single Dose Vial, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Parenteral Unit, Ahmedabad 382213, India, Amneal Pharamceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1574-01.

Amneal Pharmaceuticals of New York, LLC

Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number 70121-1573-1; Correct NDC Number 70121-1574-1.

May 8, 2023 · DrugView details →
Class IIOngoing

Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL) bottle, Distributed by: Cara Incorporated, 333 Strawberry Field Road, Warwick, RI 05886. NDC 70309-080-02

Denison Pharmaceuticals, LLC

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

May 3, 2023 · DrugView details →
Class IITerminated

Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.

SUN PHARMACEUTICAL INDUSTRIES INC

CGMP Deviations

May 3, 2023 · DrugView details →
Class IIOngoing

Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.

Denison Pharmaceuticals, LLC

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

May 3, 2023 · DrugView details →
Class IIOngoing

Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240.

Denison Pharmaceuticals, LLC

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

May 3, 2023 · DrugView details →
Class IIOngoing

Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.

Denison Pharmaceuticals, LLC

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

May 3, 2023 · DrugView details →
Class IIOngoing

FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-950-25

Apollo Care, LLC

Lack of Assurance of Sterility

May 2, 2023 · DrugView details →
Class IIOngoing

Ketamine Injection, 50 mg per 5 mL (10 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-050-05

Apollo Care, LLC

Lack of Assurance of Sterility

May 2, 2023 · DrugView details →
Class IIOngoing

VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-184-25

Apollo Care, LLC

Lack of Assurance of Sterility

May 2, 2023 · DrugView details →
Class IIOngoing

Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-500-25

Apollo Care, LLC

Lack of Assurance of Sterility

May 2, 2023 · DrugView details →
Class IIOngoing

VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-284-25

Apollo Care, LLC

Lack of Assurance of Sterility

May 2, 2023 · DrugView details →
Class IIOngoing

VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-264-25

Apollo Care, LLC

Lack of Assurance of Sterility

May 2, 2023 · DrugView details →
Class IIOngoing

VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-255-25

Apollo Care, LLC

Lack of Assurance of Sterility

May 2, 2023 · DrugView details →
Class IIOngoing

VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-185-50

Apollo Care, LLC

Lack of Assurance of Sterility

May 2, 2023 · DrugView details →
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