🍔 Food 💊 Drugs 🏥 Medical Devices
Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC61919-0688-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534 Class II

Reason: cGMP deviations

Direct Rx 20230313 Terminated
Distributed: Nationwide in the USA
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Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534 Class II

Reason: cGMP deviations

Direct Rx 20230313 Terminated
Distributed: Nationwide in the USA
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Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) 90-count bottle, NDC 61919-0250-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534 Class II

Reason: cGMP deviations

Direct Rx 20230313 Terminated
Distributed: Nationwide in the USA
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Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; b) 90-count bottle, NDC 61919-0448-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534 Class II

Reason: cGMP deviations

Direct Rx 20230313 Terminated
Distributed: Nationwide in the USA
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Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC 61919-0723-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534 Class II

Reason: cGMP deviations

Direct Rx 20230313 Terminated
Distributed: Nationwide in the USA
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Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534 Class II

Reason: cGMP deviations

Direct Rx 20230313 Terminated
Distributed: Nationwide in the USA
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Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534 Class II

Reason: cGMP deviations

Direct Rx 20230313 Terminated
Distributed: Nationwide in the USA
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Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Direct Rx Class II

Reason: cGMP deviations

Direct Rx 20230313 Terminated
Distributed: Nationwide in the USA
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Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534 Class II

Reason: cGMP deviations

Direct Rx 20230313 Terminated
Distributed: Nationwide in the USA
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Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 International Units/spray, 3.7 mL bottle, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 49884-161-11. Class II

Reason: Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay.

Endo Pharmaceuticals, Inc. 20230302 Terminated
Distributed: Nationwide in the USA and Puerto Rico
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