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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 8021–8040 of 17,773 recalls

Class IIITerminated

Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufacturer: Macleods Pharmaceuticals Ltd Al Oxalis Labs Baddi Himachal Pradesh INDIA, UPC Code 33342032186 ---- NDC 33342-321-86

Oxalis Labs

Defective Container; complaints of leakage.

January 11, 2019 · DrugView details →
Class IITerminated

Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17177 N. Laurel Park Drive Suite 233, Livonia, MI 48152.

MAJOR PHARMACEUTICALS

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

January 10, 2019 · DrugView details →
Class IITerminated

Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/30 mL (40 mg/mL) Sterile 30 mL Multiple Dose Vial, Rx Only, McGuff Compounding Pharmacy Services, Inc., Santa Ana, CA 92704

McGuff Compounding Pharmacy Services, Inc.

Presence of Particulate Matter: filmy/cloudy particulate observed in vial.

January 10, 2019 · DrugView details →
Class IITerminated

Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited Mandideep 462 046 India --- NDC 68180-441-01

Lupin Pharmaceuticals Inc.

CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.

January 9, 2019 · DrugView details →
Class ITerminated

5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Together Inc., Boynton, FL UPC 649964965644

Happy Together, Inc.

Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil

January 8, 2019 · DrugView details →
Class IITerminated

Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India ---- NDC 68180-0124-02

Lupin Pharmaceuticals Inc.

CGMP Deviation; manufacturing batch record could not be located

January 7, 2019 · DrugView details →
Class ITerminated

Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilized, 10 x 10 mg vials, Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway Halol-389 350, Gujarat, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-931-40 [vial] NDC 47335-931-44 [carton]

Sun Pharmaceutical Industries, Inc.

Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.

January 3, 2019 · DrugView details →
Class ITerminated

Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL Lyophilized, 10 x 20 mg vials, Rx Only, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway Halol-389 350, Gujarat, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC: 47335-932-40 [vial] 47335-932-44 [carton]

Sun Pharmaceutical Industries, Inc.

Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.

January 3, 2019 · DrugView details →
Class IITerminated

Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA

Lupin Pharmaceuticals Inc.

CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.

January 2, 2019 · DrugView details →
Class IITerminated

Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India Mfg. for : Heritage Pharmaceuticals Inc. NDC 23155-0216-31

Heritage Pharmaceuticals, Inc.

Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle

January 2, 2019 · DrugView details →
Class IITerminated

Methocarbamol liquid 100mg/ml, RX, glass vial

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Lack of sterility assurance.

January 2, 2019 · DrugView details →
Class IITerminated

Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA

Lupin Pharmaceuticals Inc.

CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.

January 2, 2019 · DrugView details →
Class IITerminated

Lidocaine gel 2%, RX, plastic dropper

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Lack of sterility assurance.

January 2, 2019 · DrugView details →
Class IITerminated

Hydroxyprogesterone liquid, 250mg/ml, RX, glass vial

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Lack of sterility assurance.

January 2, 2019 · DrugView details →
Class IITerminated

Glutathione liquid, 200mg/ml, Rx

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Lack of sterility assurance.

January 2, 2019 · DrugView details →
Class IITerminated

MIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vial

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Lack of sterility assurance.

January 2, 2019 · DrugView details →
Class IITerminated

Lidocaine gel 1%, RX, plastic dropper

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Lack of sterility assurance.

January 2, 2019 · DrugView details →
Class IITerminated

HCG liquid, 1000u/ml, RX, glass vial, various

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Lack of sterility assurance.

January 2, 2019 · DrugView details →
Class IITerminated

Testosteron Cypionate liquid 200mg/ml, RX, glass vial

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Lack of sterility assurance.

January 2, 2019 · DrugView details →
Class IITerminated

Cyclosporin liquid 2%, Rx, plastic dropper bottle, dry eye

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Lack of sterility assurance.

January 2, 2019 · DrugView details →
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