US Drug Recall Register
Class II · Moderate risk Terminated Initiated Dec 18, 2019 (7 years ago)

Naltrexone 4.5 mg capsule

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

Why it was recalled

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

What was recalled

Naltrexone 4.5 mg capsule

Recalling firm
MPRX, Inc. dba Medical Park Pharmacy
Origin
TX, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0810-2020

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 Hydrochloride Tablets

Reason cGMP deviations: Temperature abuse

Mckesson Medical-Surgical Inc. Corporate Office NDC 0406-1170-03 D-1039-2022
Class II · Moderate risk Terminated

Naltrexone

Reason Lack of Processing Control

The Medicine Shoppe Pharmacy D-1180-2020
Class II · Moderate risk Terminated

Vivitrol

Reason Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.

Alkermes, Inc. D-0119-2020
Class II · Moderate risk Terminated

Vivitrol

Reason Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.

Alkermes Inc D-1846-2019