US Drug Recall Register
Class II · Moderate risk Terminated Initiated Feb 9, 2018 (9 years ago)

Naltrexone HCl USP (Dihydrate) for prescription compounding, packaged in a) 1g (NDC…

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

Why it was recalled

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

What was recalled

Naltrexone HCl USP (Dihydrate) for prescription compounding, packaged in a) 1g (NDC 58597-8407-1); b) 5g (NDC 58597-8407-2); c) 25g (NDC 58597-8407-4); d) 100g (NDC 58597-8407-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Recalling firm
American Pharmaceutical Ingredients LLC
NDC code
58597-8407-1
Origin
MI, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0511-2018

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.

Other Naltrexone recalls

See all
Class II · Moderate risk Terminated

Naltrexone 4.5 mg capsule

Reason Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.

MPRX, Inc. dba Medical Park Pharmacy D-0810-2020