Methylcobalamin Injectable Recalled Due to Lack of Sterility Assurance
Family Pharmacy of Statesville is recalling Methylcobalamin 1 mg/mL Injectable in 1 mL syringes (Lot #07282020@3) distributed in North Carolina because the manufacturer cannot assure the product meets sterility standards.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is FDA Class II involving a sterility defect in an injectable drug. Lack of sterility assurance in injectable medications poses serious infection risk and meets the Severe threshold for Class II recalls with potential for serious adverse health consequences.
Plain-English summary
Family Pharmacy of Statesville is recalling Methylcobalamin 1 mg/mL Injectable in 1 mL syringes due to lack of assurance of sterility. The recalled product is a prescription injectable medication supplied in individual 1 mL syringes (Lot #07282020@3, with a beyond-use date of 8/11/2020). The product was distributed in North Carolina.
Consumers who have received this medication should contact their healthcare provider immediately. Healthcare providers should not dispense or administer any remaining stock from this lot. Patients should not use any remaining doses of this product and should speak with their doctor about alternative treatments if needed.
The recalled product
- Product
- Methylcobalamin 1 mg/mL Injectable in 1 mL syringes, Rx only, Family Pharmacy of Statesville, Inc.
- Manufacturer
- Family Pharmacy of Statesville
- Category
- Drug — Injectable / Compounded
- Hazard
- sterility-defect
- injection-infection-risk
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)
- Lot #: 07282020@3 BUD: 8/11/2020
Distribution
Distributed in 1 state:
- NC
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