Hydroxocobalamin Injection Recalled for Lack of Sterility Assurance
TMC Acquisition LLC is recalling specific batches of Hydroxocobalamin Preservative Free injectable due to lack of sterility assurance. The affected vials were distributed nationwide in the USA and Puerto Rico.
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 a preservative-free injectable medication with compromised sterility assurance, which poses a theoretical risk of harm to patients. No illnesses or injuries have been reported, fitting the criterion for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
TMC Acquisition LLC dba Tailor Made Compounding is recalling Hydroxocobalamin Preservative Free 5mg/mL injectable medication due to a lack of assurance of sterility. The recalled product consists of 1mL vials that require refrigeration.
The recall affects batches #01032236A2 (expiration date 4/3/2022) and #03072232A1 (expiration date 6/5/2022). These vials were distributed nationwide throughout the United States and Puerto Rico. A total of 26 vials are involved in this recall.
The FDA classified this recall as a Class II action. Healthcare providers and patients with the affected batches should not use them and should contact their pharmacy or healthcare provider for guidance.
The recalled product
- Product
- Hydroxocobalamin Preservative Free 5mg/mL, 1mL-vial, Refrigerate, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Category
- Drug — Injectable / Vitamin
- Hazard
- sterility-assurance
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 (4)
- Batch #: 01032236A2
- Exp 4/3/2022
- 03072232A1
- Exp 6/5/2022
Distribution
Distributed nationwide across the United States.
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