Category
Drug and pharmaceutical recalls
17689 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2022-06-22FDA-DrugWalmart IncClass IArtri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, 100-count bottles, Melchor Ocampo No. 55 Local D, Delegacion Xochimilco, C.P. 16800, Mexico, D.F., UPC 7 501031 111190.
Marketed Without An Unapproved NDA/ANDA: Product lot found to be tainted with undeclared diclofenac, an FDA approved nonsteroidal anti-inflammatory drug (NSAID) for the treatment of pain and inflammation.
- 2022-06-22FDA-DrugLupin Pharmaceuticals Inc.Class IIZileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin Limited, Nagpur-441108, India, NDC 68180-169-16
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
- 2022-06-22FDA-DrugHand Sanitizer LLCClass IIHAND SANITIZER SAY GOODBYE TO GERMS Alcohol Antiseptic 80% Topical Non-Sterile Solution, 12 FL OZ (254 mL) bottles, Distributed by: Hand Cleansing Gel 850 Kaliste Saloom Rd. Suite 212 Lafayette, LA 70508 UPC 8 60003 62626 9
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
- 2022-06-22FDA-DrugAMS Packaging IncClass IIPremium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), 8 oz/ 236 ML plastic bottles; Premium Nature, South Plainfield, NJ. UPC 819192028668
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
- 2022-06-22FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IImedroxyPROGESTERone Acetate Injectable Suspension, USP, 25 x 1 mL Single-Dose Vial, 150 mg/mL, 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 16714-090-40 packaged in 25 count carton.
Lack of assurance of sterility
- 2022-06-22FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IImedroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Single-Dose Vial, 150 mg/mL, Rx only, Manufactured for: Northstart Rx LLC, Memphis, TN, 38141, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol Baroda Highway, Halol-389 350, Gujarat India , NDC 16714-981-01.
Lack of assurance of sterility
- 2022-06-22FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IImedroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, 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 62756-091-40.
Lack of assurance of sterility
- 2022-06-22FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IImedroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 16714-999-01.
Lack of assurance of sterility
- 2022-06-22FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IImedroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India Distributed by: Afaxys Pharma, LLC, Charleston, SC, 29403, USA, Product of Italy, NDC 50102-591-40.
Lack of assurance of sterility
- 2022-06-22FDA-DrugA.P. NonweilerClass IIAlcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-Sterile Solution, Packaged as (a) 250 U.S. gallons per tote, Product Code 9999D361-250: (b) 1 U.S. gallon, Product Code 9999D361-001: A.P. Nonweiler Co., Inc., 3321 County Road A, Oshkosh, WI 54901.
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
- 2022-06-22FDA-DrugWashington Homeopathic Products, Inc.Class IIVaccinotoxinum, Potency: 32X, 11C, 30C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
cGMP deviations
- 2022-06-22FDA-DrugWashington Homeopathic Products, Inc.Class IITuberculinum Bovinum, Potency: 12C, 30C, 200C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
cGMP deviations
- 2022-06-22FDA-DrugWashington Homeopathic Products, Inc.Class IITuberculinum, Potency: 1X, 12X, 24X, 30X, 1M, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
cGMP deviations
- 2022-06-22FDA-DrugWashington Homeopathic Products, Inc.Class IISyphilinum, Potency: 9C, 30C, 200C, 10X, 12X, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
cGMP deviations
- 2022-06-22FDA-DrugWashington Homeopathic Products, Inc.Class IIStreptococcinum, Potency: 8C, 9C, 30C, 200C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
cGMP deviations
- 2022-06-22FDA-DrugWashington Homeopathic Products, Inc.Class IIPyrogenium, Potency: 15X, 16X, 17X, 19X, 21X, 22X, 25X, 30X, 1M, 200C, 30C, OTC, Liquid Pellets, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
cGMP deviations
- 2022-06-22FDA-DrugWashington Homeopathic Products, Inc.Class IIProteus, Potency: 7C, 8C, 9C, 12C, 15C, 16C, 20C, 30C, 200C, OTC, Liquid Pellets, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
cGMP deviations
- 2022-06-22FDA-DrugWashington Homeopathic Products, Inc.Class IIPertussinum, Potency: 19C, 30C, 200C, 1M, Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
cGMP deviations
- 2022-06-22FDA-DrugWashington Homeopathic Products, Inc.Class IIMorbillinum, Potency:7C, 8C, 9C, 10C 12C, 13C, 15C, 20C, 21C, 30C, 200 C,Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
cGMP deviations
- 2022-06-22FDA-DrugWashington Homeopathic Products, Inc.Class IIMedorrhinum, Potency:12C, 30C, 200C, 1M, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
cGMP deviations
- 2022-06-22FDA-DrugWashington Homeopathic Products, Inc.Class IIInfluenzinum, Potency: 9X, 10X, 12X, 15X, 25X, 30X, 200C, 12C, 30C 1M, Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
cGMP deviations
- 2022-06-22FDA-DrugWashington Homeopathic Products, Inc.Class IIDiphtherinum, Potency: 14C, 30C, 200C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411,
cGMP deviations
- 2022-06-22FDA-DrugWashington Homeopathic Products, Inc.Class IIColibacillinum, Potency: 12C, 14C, 15C, 18C, 20C, 30C, Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
cGMP deviations
- 2022-06-22FDA-DrugWashington Homeopathic Products, Inc.Class IICandida Parapsilosis, Potency: 14X, 15X, 16X, 20X, 28X, 30X, 9C, 10C, 13C, 15C, 25C, 30C, 13X, 27X, 30X, Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
cGMP deviations
- 2022-06-22FDA-DrugWashington Homeopathic Products, Inc.Class IICandida Albicans, Potency: 9C, 10C, 12C, 13C, 14C 15C 16C, 19C, 24C, 25C, 26C, 30C, 200C, 14X, 15X, 16X, 20X, 288X, 30X, Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
cGMP deviations
- 2022-06-22FDA-DrugWashington Homeopathic Products, Inc.Class IIBacillinum Pulmo, Potency: 30C, 200C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
cGMP deviations
- 2022-06-22FDA-DrugWashington Homeopathic Products, Inc.Class IIAnthracinum, Potency: 6C, 7C, 8C, 9C, 12C, 14C, 30C, 200C, 11X, 14X, 30X Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way Berkeley Springs, WV 25411
cGMP deviations
- 2022-06-15FDA-DrugValor Compounding Pharmacy, Inc DBA Valor Compounding PharmacyClass ITacrolimus (Brand Capsules ) 0.5 mg/mL Suspension, Rx, This is a compounded medication., Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 94704
Subpotent drug
- 2022-06-15FDA-DrugValor Compounding Pharmacy, Inc DBA Valor Compounding PharmacyClass ITacrolimus (Brand Capsules ) 0.5 mg/mL Suspension, Rx, This is a compounded medication., Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 94704,
Subpotent drug
- 2022-06-15FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IIParacentesis/Thoracentises Tray (10/cs) Rx CRFPED, Lidocaine Hydrochloride USP, 1%, 5mL, Rx only, MFG: Becton Dickinson
cGMP deviations: Temperature abuse
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