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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 5
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:
Part of a larger recall action
This product is one of 12 recalled by Family Pharmacy of Statesville under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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