FDA recall D-0220-2023

Pharmacy Innovations · Class II · drug

Product

METHION/INOSIT/CHOLINE/CYANOCOBAL 25MG/50MG/50MG/1MG/ML (1ML VIAL) INJECTABLE; METHION/INOSIT/CHOLINE/METHYLCOBAL 15MG/50MG/100MG/1MG/ML (1ML VIAL) INJECTABLE; METHION/INOSIT/CHOLINE/RIBOFLA/NIACINAMIDE/PYRIDOX/ASCORBIC ACID 15.625MG/31.25MG/31.25MG/6.25MG/62.5MG/6.25MG/62.5MG/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Reason for recall

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2022-12-22
Report date: 2023-02-01
Termination date: 2024-07-31
Voluntary/Mandated: Voluntary: Firm initiated
Location: Erie, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0220-2023