Methylcobalamin Injectable Recalled Due to Lack of Sterility Assurance
Tailor Made Compounding is recalling Methylcobalamin Preservative Free 10mg/mL injectable due to lack of assurance of sterility. The affected batch may not meet sterility standards required for injectable medications.
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 sterility assurance issue for an injectable medication. No illnesses or injuries have been reported, making the hazard theoretical rather than confirmed. Per the severity rubric, recalls with theoretical hazards and no reported illnesses score at most 3 (High).
Plain-English summary
Tailor Made Compounding is recalling Methylcobalamin Preservative Free, 10mg/mL in 1mL vials. The recall affects batch 03012234A1 with an expiration date of August 28, 2022.
The product is being recalled due to lack of assurance of sterility. As an injectable medication intended for intravenous or intramuscular administration, the product must meet strict sterility standards. The manufacturer cannot confirm that the affected batch meets these standards.
The affected product was distributed nationwide throughout the United States and Puerto Rico. Healthcare providers and patients who may have received this product should contact Tailor Made Compounding or the FDA with any questions or to report any adverse effects.
The recalled product
- Product
- Methylcobalamin Preservative Free, 10mg/mL, 1mL-vial, Room Temperature, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Category
- Drug — Injectable / Compounded
- Hazard
- lack-of-sterility
- 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 (2)
- Batch#: 03012234A1
- Exp 8/28/2022.
Distribution
Distributed nationwide across the United States.
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