Dexpanthenol injectable vials recalled for lack of sterility assurance
Tailor Made Compounding is recalling 19 vials of Dexpanthenol 250mg/mL due to lack of assurance of sterility. Two batches with different expiration dates 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 a risk-of-harm product where a lack of sterility assurance in an injectable medication creates potential for serious infection, with no reported illnesses or injuries to date. This fits the rubric criterion for high-risk products where injury has not yet been reported.
Plain-English summary
Tailor Made Compounding is recalling Dexpanthenol 250mg/mL injectable solution in 30mL vials due to lack of assurance of sterility. The recall involves 19 vials from two batches: Batch #01032232A1 with expiration date 7/2/2022 and Batch #01242229A2 with expiration date 7/23/2022.
The recalled product was distributed nationwide throughout the USA and Puerto Rico.
Patients and healthcare providers who may have received this product should verify whether they have vials from the recalled batches by checking the batch number and expiration date. Any concerns about exposure should be reported to a healthcare provider or the FDA.
The recalled product
- Product
- Dexpanthenol 250mg/mL, 30mL-vial, Room Temperature, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Category
- Drug — Injectable
- 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 #: 01032232A1
- Exp 7/2/2022
- 01242229A2
- Exp 7/23/2022.
Distribution
Distributed nationwide across the United States.
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