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FDA Drug Recalls

18043 recall notices on file. Class I recalls involve a reasonable probability of serious adverse health consequences or death.

ProductFirmClassificationStatusReport date
Amitriptyline HCl USP for prescription compounding , packaged in a) 25 g (NDC 58597-8003-4); b) 100 g (NDC 58597-8003-6); c) 500 g (NDC 58597-8003-7), d) 1000 g (NDC 58597-8003-8), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327. American Pharmaceutical Ingredients LLC Class II Terminated 20180228
Calcium Acetate Capsules, 667 mg, 200 Capsules per bottle, Rx Only. Manufactured by Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-026-02 Nostrum Laboratories Inc Class III Terminated 20180228
Nicardipine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Dexamethasone Sodium Phosphate added to 5% Dextrose in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Rocuronium Bromide in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Methadone HCl Injection in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Meperidine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Esmolol HCl in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Dexamethasone Sodium Phosphate added to 0.9% Sodium Chloride in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Vecuronium Bromide in Sterile Water for Injection in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Neostigmine Methylsulfate Injection in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Labetalol HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Nicardipine HCl in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Ropivacaine HCl Injection in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
HYDROmorphone HCl in 5% Dextrose in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Atropine Sulfate Injection in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Lidocaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Glycopyrrolate in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Ropivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Ketamine HCl Injection in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Ephedrine Sulfate Injection in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Fentanyl Citrate Injection in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Midazolam HCl Injection in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Methadone HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Labetalol HCl in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Potassium Chloride in 5% Dextrose in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Phenylephrine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Dexamethasone Sodium Phosphate in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Adenosine Injection in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Succinylcholine Chloride in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Ketamine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Potassium Chloride in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Fentanyl Citrate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Lidocaine HCl in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Morphine Sulfate in 5% Dextrose in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Morphine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Midazolam HCl in 5% Dextrose in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Midazolam HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
HYDROmorphone HCl Injection in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Ephedrine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Fentanyl Citrate and Bupivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Fentanyl Citrate and Ropivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Bupivacaine HCl in 0.9% Sodium Chloride in all doses, all strengths, and packaging. Pharmedium Services, LLC Class II Terminated 20180228
HYDROmorphone HCl in Sodium Chloride 0.9% in all doses, all strengths, and all packaging. Pharmedium Services, LLC Class II Terminated 20180228
Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit -VII (SEZ)) Mahabubnagar (Dt)_509302 India, NDC 65862-010-05. Aurobindo Pharma Ltd. Class III Terminated 20180228
HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial, Sterile, Rx Only, Compounded by The Compounding Pharmacy of America, 6216 Highland Place Way, Ste. 101A Knoxville, TN 37919 Ph (855) 277-2488 Fax (888) 689-9892 The Compounding Pharmacy of America Class I Terminated 20180221
Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11; UPC (01) 003 60687 179 11 7] per carton (NDC 60687-179-01), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. AMERICAN HEALTH PACKAGING Class II Terminated 20180221
Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, INC., North Wales, PA 19454, NDC 0093-7188-56 Teva Pharmaceuticals USA Class III Terminated 20180221
100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe, Rx only, PharMEDium Serivces, LLC PharMEDium Services, LLC Class II Terminated 20180221
0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette, Rx only, PharMEDium Serivces, LLC PharMEDium Services, LLC Class II Terminated 20180221