US Drug Recall Register
Class II · Moderate risk Terminated Initiated Apr 3, 2018 (8 years ago)

Azithromycin 250 mg tablet #18 TEV NDC 50111-0787-66 28 days supply

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Processing Controls.

What was recalled

Azithromycin 250 mg tablet #18 TEV NDC 50111-0787-66 28 days supply

Recalling firm
Kroger Specialty Pharmacy, Inc.
NDC code
50111-0787-66
Origin
MS, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0754-2018

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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Reason CGMP Deviations: Firm did not adequately investigate customer complaints.

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Reason CGMP Deviations: Firm did not adequately investigate customer complaints.

American Health Packaging NDC 68084-464-11 D-1222-2015
Class II · Moderate risk Terminated

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Reason CGMP Deviations: Firm did not adequately investigate customer complaints.

American Health Packaging NDC 68084-279-11 D-1221-2015
Class II · Moderate risk Terminated

Azithromycin 500 mg tablets

Reason cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.

PD-Rx Pharmaceuticals, Inc. D-0561-2016