medroxyPROGESTERone 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. Class II

Reason: Lack of assurance of sterility

SUN PHARMACEUTICAL INDUSTRIES INC 20220506 Terminated
Distributed: USA Nationwide
medroxyPROGESTERone 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. Class II

Reason: Lack of assurance of sterility

SUN PHARMACEUTICAL INDUSTRIES INC 20220506 Terminated
Distributed: USA Nationwide
medroxyPROGESTERone 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. Class II

Reason: Lack of assurance of sterility

SUN PHARMACEUTICAL INDUSTRIES INC 20220506 Terminated
Distributed: USA Nationwide
Alcohol 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. Class II

Reason: CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.

A.P. Nonweiler 20220511 Ongoing
Distributed: Distributed in States of WI and VA
Vaccinotoxinum, Potency: 32X, 11C, 30C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 Class II

Reason: cGMP deviations

Washington Homeopathic Products, Inc. 20220513 Terminated
Distributed: Product was distributed USA nationwide.
Tuberculinum Bovinum, Potency: 12C, 30C, 200C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 Class II

Reason: cGMP deviations

Washington Homeopathic Products, Inc. 20220513 Terminated
Distributed: Product was distributed USA nationwide.
Tuberculinum, Potency: 1X, 12X, 24X, 30X, 1M, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 Class II

Reason: cGMP deviations

Washington Homeopathic Products, Inc. 20220513 Terminated
Distributed: Product was distributed USA nationwide.
Syphilinum, Potency: 9C, 30C, 200C, 10X, 12X, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 Class II

Reason: cGMP deviations

Washington Homeopathic Products, Inc. 20220513 Terminated
Distributed: Product was distributed USA nationwide.
Streptococcinum, Potency: 8C, 9C, 30C, 200C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 Class II

Reason: cGMP deviations

Washington Homeopathic Products, Inc. 20220513 Terminated
Distributed: Product was distributed USA nationwide.
Pyrogenium, 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 Class II

Reason: cGMP deviations

Washington Homeopathic Products, Inc. 20220513 Terminated
Distributed: Product was distributed USA nationwide.
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