Recalls / Class II

Class IID-0220-2023

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.

Affected lot / code info

t20221011@25 t20221025@48 t20221115@36

Why it was recalled

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

Recalling firm

Firm

Pharmacy Innovations

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

2936 W 17th St, N/A, Erie, Pennsylvania 16505-3929

Distribution

Quantity

N/A

Distribution pattern

Nationwide in the USA

Timeline

Recall initiated

2022-12-22

FDA classified

2023-01-26

Posted by FDA

2023-02-01

Terminated

2024-07-31

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0220-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.