🍔 Food 💊 Drugs 🏥 Medical Devices
Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale -Bardez, Goa 403513, India, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-295-01 Class III

Reason: Subpotent: Out of Specification for Assay Test at the 3-month time point.

Glenmark Pharmaceuticals Inc., USA 20230814 Ongoing
Distributed: nationwide in the U.S.
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Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC: 71384-311-05. Class III

Reason: Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.

Imprimis NJOF, LLC 20230810 Terminated
Distributed: Nationwide in the US
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Helix CBD Clinical Cream (Menthol 7.4%), packaged in a)3 gm pouches (NDC30775-054-01), b)2 fl. oz. tubes (NDC 30775-054-02), and c) 4 fl. oz. tubes (NDC 30775-054-04), Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004 Class II

Reason: CGMP Deviations

Parker Laboratories, Inc. 20230802 Terminated
Distributed: Nationwide within the United States, Singapore, Korea and Hong Kong
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Helix CBD Therapy Cream (Menthol 7.4%), packaged in a) 3 g pouch (NDC 30775-053-01), b) 2 fl. oz. tubes (NDC 30775-053-02), c) 4 fl. oz. tubes (NDC 30775-053-04), Parker Laboratories Inc., Fairfield, NJ, 07004 Class II

Reason: CGMP Deviations

Parker Laboratories, Inc. 20230802 Terminated
Distributed: Nationwide within the United States, Singapore, Korea and Hong Kong
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Helix Tri-Active Therapy Cream (Camphor 3.2%, Menthol 7.4%, Methyl salicylate 12.5%), packaged in a) 3 fl. oz. roll-on (NDC 30775-052-03) and b) 4 fl. oz. tube (NDC 30775-052-04) Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004 Class II

Reason: CGMP Deviations

Parker Laboratories, Inc. 20230802 Terminated
Distributed: Nationwide within the United States, Singapore, Korea and Hong Kong
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Helix Pain Relieving Cream (Menthol 7.4%), packaged in a) 5 gm pouch (NDC 30775-051-01), b) 3 fl. oz. roll-on (NDC 30775-051-03), c) 4 fl. oz. tubes (NDC 30775-051-04), d) 12 fl oz pump bottles (NDC 30775-051-12), e) 32 fl. oz. pump bottles (NDC 30775-051-32), f) 1 U.S. gallon with pump (NDC 30775-051-50), g) Starter Kit (NDC 30775-051-95), Parker Laboratories, Inc. 286 Eldridge Road Fairfield, NJ 07004 Class II

Reason: CGMP Deviations

Parker Laboratories, Inc. 20230802 Terminated
Distributed: Nationwide within the United States, Singapore, Korea and Hong Kong
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Protex Foaming Hand Sanitizer (Benzalkonium Chloride 0.13%), packaged in a) 2 fl oz/60 mL Pump bottles (NDC 30775-040-02) and b)18 fl. oz./550 ml Pump Bottles (NDC 30775-040-18), Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004 Class II

Reason: CGMP Deviations

Parker Laboratories, Inc. 20230802 Terminated
Distributed: Nationwide within the United States, Singapore, Korea and Hong Kong
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Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-617-08 Class II

Reason: cGMP deviations: Batch was released prior to approval.

Aurobindo Pharma USA Inc. 20230721 Terminated
Distributed: USA nationwide
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Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-616-08 Class II

Reason: cGMP deviations: Batch was released prior to approval.

Aurobindo Pharma USA Inc. 20230721 Terminated
Distributed: USA nationwide
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Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05 Class III

Reason: Failed Impurities/Degradation Specifications

ALEMBIC PHARMACEUTICALS, INC. 20230727 Ongoing
Distributed: Nationwide in the USA
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