Dexpanthenol Preservative Free Injectable Recalled Due to Sterility Assurance Failure
Tailor Made Compounding recalls 84 vials of Dexpanthenol Preservative Free due to lack of assurance of sterility. The medication was distributed nationwide and in 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 of a preservative-free injectable medication without reported illnesses or injuries. The lack of assurance of sterility represents a risk-of-harm product where injury has not yet been reported, meeting the rubric criterion for High (3) severity.
Plain-English summary
Tailor Made Compounding (TMC Acquisition LLC) is recalling Dexpanthenol Preservative Free 250mg/mL in 2mL vials due to lack of assurance of sterility. The recall involves 84 vials with batch numbers 01032234A2 (expiration 7/2/2022) and 02072212A1 (expiration 8/6/2022).
Dexpanthenol Preservative Free is an injectable medication formulated without preservatives. Lack of assurance of sterility means the manufacturer has not established adequate evidence that the product is sterilized and free from microorganisms.
The affected product was distributed nationwide in the United States and Puerto Rico under FDA recall classification D-1200-2022.
The recalled product
- Product
- Dexpanthenol Preservative Free 250mg/mL, 2mL-vial, Room Temperature, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Hazard
- lack-of-sterility
- contamination-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 (4)
- Batch#: 01032234A2
- Exp 7/2/2022
- 02072212A1
- Exp 8/6/2022.
Distribution
Distributed nationwide across the United States.
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