PT-141 10mg/mL Injectable Vials Recalled for Sterility Assurance Concerns
Tailor Made Compounding is recalling PT-141 10mg/mL vials nationwide due to inability to assure sterility. The recall affects 392 vials in 1mL and 2mL sizes distributed in 2022.
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 FDA Class II recall involves a potential for microbial contamination in an injectable drug product. The source reports no illnesses or injuries and the hazard is theoretical, placing this at the High severity level per the rubric.
Plain-English summary
Tailor Made Compounding is recalling PT-141 10mg/mL vials due to lack of assurance of sterility. The recall affects 392 vials in two sizes: 1mL and 2mL vials that require refrigeration.
The reason for the recall is that the manufacturer cannot assure that the vials meet sterility requirements. This is a Class II recall issued by the U.S. Food and Drug Administration.
The affected vials were distributed nationwide in the United States and Puerto Rico. The specific batch numbers are: for 1mL vials - 01042226A2 (expires 4/4/2022), 01242228A2 (expires 4/24/2022), 02212208A1 (expires 5/22/2022); for 2mL vials - 01192230A2 (expires 4/19/2022), 02212217A1 (expires 5/22/2022).
Consumers or healthcare providers who have these products should not use them and should contact Tailor Made Compounding.
The recalled product
- Product
- PT-141 10mg/mL a) 1mL-vial, b) 2 mL-vial, Refrigerate, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Category
- Drug
- Hazard
- sterility-assurance
- microbial-contamination
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 (10)
- Batch#: a) 01042226A2
- Exp 4/4/2022
- 01242228A2
- Exp 4/24/2022
- 02212208A1
- Exp 5/22/2022
- b) 01192230A2
- Exp 4/19/2022
- 02212217A1
- Exp 5/22/2022.
Distribution
Distributed nationwide across the United States.
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