🍔 Food 💊 Drugs 🏥 Medical Devices
Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03), b) 90-count bottles (NDC 70518-0405-00) and c)180-count bottles (NDC 70518-0405-02), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701 Class II

Reason: cGMP Deviations

RemedyRepack Inc. 20230320 Terminated
Distributed: RemedyRepack distributed product to consignees nationwide within the United States
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Doxazosin 2 mg tablets, packaged in a) 30-count (NDC 70518-1560-00) and b) 90-count bottles (NDC 70518-1560-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. Class II

Reason: cGMP Deviations

RemedyRepack Inc. 20230320 Terminated
Distributed: RemedyRepack distributed product to consignees nationwide within the United States
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Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-00) and b) 90-count bottles (NDC 70518-1946-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. Class II

Reason: cGMP Deviations

RemedyRepack Inc. 20230320 Terminated
Distributed: RemedyRepack distributed product to consignees nationwide within the United States
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Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2921-03 Class II

Reason: cGMP Deviations

RemedyRepack Inc. 20230320 Terminated
Distributed: RemedyRepack distributed product to consignees nationwide within the United States
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Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10) and b) 1 mL single dose vials (NDC 52536-625-01), Rx only, Mfd for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328. Class II

Reason: cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.

Azurity Pharmaceuticals, Inc. 20230215 Terminated
Distributed: US Nationwide
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Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-475-60. Class II

Reason: CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.

Ascend Laboratories, LLC 20230314 Ongoing
Distributed: Nationwide in the USA.
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Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-474-60. Class II

Reason: CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.

Ascend Laboratories, LLC 20230314 Ongoing
Distributed: Nationwide in the USA.
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Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mojave Ct. Suite 101, Columbia, MO 65202, NDC 71170-950-25 Class II

Reason: Lack of assurance of sterility: Suspected microbial growth present on external label packaging.

Apollo Care 20230208 Ongoing
Distributed: MO
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Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, 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, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC 61919-0446-90, 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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