🍔 Food 💊 Drugs 🏥 Medical Devices
DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15 Class II

Reason: cGMP deviations

Homeocare Laboratories, Inc. 20230605 Terminated
Distributed: Product was distributed USA nationwide.
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Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-035-01 Class II

Reason: cGMP deviations

Homeocare Laboratories, Inc. 20230605 Terminated
Distributed: Product was distributed USA nationwide.
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Bebelyn Colic Drops Homeopathic Remedy, 0.5 FL Oz (15 mL) bottles, distributed by Pharmadel LLC Georgetown, DE NDC 55758-036-01 Class II

Reason: cGMP deviations

Homeocare Laboratories, Inc. 20230605 Terminated
Distributed: Product was distributed USA nationwide.
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Arnica 7 Cream, net wt 2 oz (56.7g), Manufactured for: Brazmedics, LLC, New York, NY 10021 UPC 8 60208 00181 6 Class II

Reason: cGMP deviations

Homeocare Laboratories, Inc. 20230605 Terminated
Distributed: Product was distributed USA nationwide.
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Kanjo Homeopathic Pain Relief Cream With Arnica, NET WT 2 oz (56.70G), Manufactured For: Acutens, Inc., Sheridan, WY NDC 80551-201-02 Class II

Reason: cGMP deviations

Homeocare Laboratories, Inc. 20230605 Terminated
Distributed: Product was distributed USA nationwide.
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Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 vaginal inserts with 21 disposable vaginal applicators, Manufactured for: Ferring Pharmaceuticals Inc., Parsippany, NJ NDC# 55566-6500-03 Class II

Reason: cGMP deviations: potential for Microbial Contamination of Non-Sterile Products

Ferring Pharmaceuticals Inc 20230612 Terminated
Distributed: USA Nationwide
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Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-7179-61 Class II

Reason: Packaging defect: blister packaging inadequately sealed.

The Harvard Drug Group 20230616 Terminated
Distributed: Nationwide in the U.S.
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ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally-500 090 India, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-6269-08 Class I

Reason: Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 20230531 Terminated
Distributed: Nationwide in the USA
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Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01 Class III

Reason: Failed Impurities/Degradation Specifications

Aurolife Pharma, LLC 20230518 Terminated
Distributed: Nationwide within the United States
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Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater, NJ 08807, NDC 65162-212-10. Class II

Reason: Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)

Amneal Pharmaceuticals of New York, LLC 20230530 Terminated
Distributed: LA, PA and OH.
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