🍔 Food 💊 Drugs 🏥 Medical Devices
Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram- 603 110, Tamilnadu, India, NDC 64380-933-08 Class II

Reason: Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.

Strides Pharma Inc. 20230626 Terminated
Distributed: Nationwide in the USA.
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Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (NDC: 68788-7781-3), c) 60-count bottles, (NDC: 68788-7781-6), d) 90-count bottles (NDC: 68788-7781-9), e) 120-count bottles (NDC: 68788-7781-8), Rx only, Mfg: Dr. Reddy's Laboratories Limited. Class II

Reason: Failed Stability Specifications

Preferred Pharmaceuticals, Inc. 20230626 Ongoing
Distributed: Nationwide within the United States
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Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-645-01 (carton), barcode (01) 003 68084 645 11 2. Class II

Reason: Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.

Amerisource Health Services LLC 20230623 Terminated
Distributed: Nationwide in the USA
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Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti, Halol-389350, Gujarat, India, NDC 62756-0233-01 Class II

Reason: Subpotent drug

SUN PHARMACEUTICAL INDUSTRIES INC 20230530 Terminated
Distributed: USA nationwide
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StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-112-01 Class II

Reason: cGMP deviations

Homeocare Laboratories, Inc. 20230605 Terminated
Distributed: Product was distributed USA nationwide.
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StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-102-02 Class II

Reason: cGMP deviations

Homeocare Laboratories, Inc. 20230605 Terminated
Distributed: Product was distributed USA nationwide.
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StellaLife VEGA Oral Care Spray, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-101-02 Class II

Reason: cGMP deviations

Homeocare Laboratories, Inc. 20230605 Terminated
Distributed: Product was distributed USA nationwide.
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StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Coconut, Distributed by: StellaLife, Aventura, FL NDC 69685-113-16 Class II

Reason: cGMP deviations

Homeocare Laboratories, Inc. 20230605 Terminated
Distributed: Product was distributed USA nationwide.
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StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-103-16 Class II

Reason: cGMP deviations

Homeocare Laboratories, Inc. 20230605 Terminated
Distributed: Product was distributed USA nationwide.
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SnoreStop Naso Spray Bulk, liquid, Distributed by Green Pharma, NDC 61152-199-99 Class II

Reason: cGMP deviations

Homeocare Laboratories, Inc. 20230605 Terminated
Distributed: Product was distributed USA nationwide.
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