The Recall Desk
HighFDA (Drugs)·D-0220-2023·Announced 2023-02-01

Injectable vitamin formulations recalled due to facility sterility concerns

Pharmacy Innovations is recalling three injectable vitamin formulations due to insanitary facility conditions identified during FDA inspection that may affect product sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving injectable products with potential sterility issues due to insanitary facility conditions. Although the product category carries inherent risk due to direct injection route, no illnesses or injuries have been reported, and the hazard is theoretical rather than confirmed contamination.

Plain-English summary

Pharmacy Innovations, located at 2936 W 17th St., Erie, PA, is recalling three injectable vitamin formulations due to insanitary conditions discovered during a U.S. Food and Drug Administration inspection. The affected products contain combinations of methionine, inositol, choline, and B vitamins in 1 mL vials.

The recalled formulations include Cyanocobalamin (25 mg/50 mg/50 mg/1 mg/mL), Methylcobalamin (15 mg/50 mg/100 mg/1 mg/mL), and Riboflavin/Niacinamide/Pyridoxine/Ascorbic Acid formulations. Affected lot numbers are t20221011@25, t20221025@48, and t20221115@36, distributed nationwide.

The FDA inspection revealed insanitary conditions at the manufacturing facility that may have affected the sterility assurance of these injectable products. No illnesses or adverse events have been reported.

Healthcare providers and patients should discontinue use of recalled products and consult their healthcare provider about alternatives. Distributors and healthcare facilities should quarantine recalled product and cease distribution.

The recalled product

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
Manufacturer
Pharmacy Innovations
Category
Drug — Injectable Vitamins
Hazard
  • sterility-assurance
  • insanitary-conditions

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • t20221011@25 t20221025@48 t20221115@36

Distribution

Distributed nationwide across the United States.

Related recalls

Same category