🍔 Food 💊 Drugs 🏥 Medical Devices
OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA, 93436, USA, NDC 59883-500-01, UPC: 3 59883 00000 4. Class II

Reason: CGMP Deviations: products may not conform to the labeled specifications.

Den-Mat Holdings, LLC 20240116 Ongoing
Distributed: Nationwide in the US
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Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-575-21; NDC Unit Dose: 60687-575-11 Class II

Reason: Failed Impurities/Degradation Specification.

Amerisource Health Services LLC 20240111 Terminated
Distributed: Nationwide in the USA
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Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-659-06 Class II

Reason: Subpotent Drug and Failed Impurities/Degradation Specifications

Lupin Pharmaceuticals Inc. 20240105 Terminated
Distributed: Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.
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Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-658-06 Class II

Reason: Subpotent Drug and Failed Impurities/Degradation Specifications

Lupin Pharmaceuticals Inc. 20240105 Terminated
Distributed: Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.
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VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-029-68. Class I

Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

Denver Solutions, LLC DBA Leiters Health 20231228 Ongoing
Distributed: Nationwide within the United States
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VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-028-68. Class I

Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

Denver Solutions, LLC DBA Leiters Health 20231228 Ongoing
Distributed: Nationwide within the United States
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PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-150-82. Class I

Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

Denver Solutions, LLC DBA Leiters Health 20231228 Ongoing
Distributed: Nationwide within the United States
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PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-148-94. Class I

Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

Denver Solutions, LLC DBA Leiters Health 20231228 Ongoing
Distributed: Nationwide within the United States
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FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-82. Class I

Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

Denver Solutions, LLC DBA Leiters Health 20231228 Ongoing
Distributed: Nationwide within the United States
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FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-41. Class I

Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

Denver Solutions, LLC DBA Leiters Health 20231228 Ongoing
Distributed: Nationwide within the United States
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