BCAA Injection Vials Recalled for Lack of Sterility Assurance
Tailor Made Compounding is recalling 180 vials of BCAA (branched-chain amino acid) injections nationwide due to inability to assure the product maintained sterility. Affected batches expire between April and June 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 recall received a High severity rating because it involves a risk-of-harm product (injectable medication) with theoretical risk based on lack of sterility assurance but no reported illnesses or injuries. Per FDA rubric, such risk-of-harm products without reported injury score at maximum 3.
Plain-English summary
Tailor Made Compounding is recalling BCAA (branched-chain amino acid) injections due to lack of assurance of sterility. The recalled product contains leucine, isoleucine, and valine in a concentration of 10mg/10mg/5mg per mL, supplied in 30mL vials. Approximately 180 vials were distributed nationwide in the United States and Puerto Rico.
The affected batches are: Batch #11022106A1 (expires 4/30/2022), #11192106A2 (expires 5/18/2022), #12022105A1 (expires 5/31/2022), #12132108A1 (expires 6/11/2022), and #12292117A1 (expires 6/27/2022).
The FDA classified this recall as Class II because the manufacturer was unable to provide assurance that the product maintained sterility. No illnesses or injuries from use of these vials have been reported.
The recalled product
- Product
- BCAAs (Leucine/Iso-Leucine/Valine) 10mg/10mg/5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Category
- Drug — Injectables
- Hazard
- sterility-failure
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 #: 11022106A1
- Exp 4/30/2022
- 11192106A2
- Exp 5/18/2022
- 12022105A1
- Exp 5/31/2022
- 12132108A1
- Exp 6/11/2022
- 12292117A1
- Exp 6/27/2022.
Distribution
Distributed nationwide across the United States.
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