Class II · Moderate risk Terminated
Naltrexone Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, MFG: Mallinckrodt Inc., NDC 0406-1170-03
Reason cGMP deviations: Temperature abuse
NALTREXONE 1 MG/ML INJECTABLE and 200 MG/ML INJECTABLE, all presentations, FOR INTRAVENO…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
What was recalled
NALTREXONE 1 MG/ML INJECTABLE and 200 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
- Recalling firm
- Beacon Hill Medical Pharmacy, P.C.
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-984-2013
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/mL Suspension 30 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
Reason Lack of Processing Control
Class II · Moderate risk Terminated
Naltrexone (Loxoral) 4.5 mg Capsules, 60 count bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
Reason Lack of Processing Control
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.
Class II · Moderate risk Terminated
Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains: 1) One vial of 380 mg of…
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…
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