Recalls / Class II
Class IID-1227-2022
Product
Sermorelin/Glycine 2000mcg/5mg/mL, 4mL-vial, Refrigerate, Tailor Made Compounding
- Affected lot / code info
- Batch#: 11102107A2, Exp 4/9/202211232104A1, Exp 5/7/2022; 02212229A1, 11292103A2, Exp 5/22/2022; 12132105A2, Exp 5/24/2022; 02282207A1, Exp 5/29/2022; 03082209A1, Exp 6/6/2022; 03112231B, Exp 6/9/2022; 01042212A1, Exp 6/27/2022.
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- TMC Acquisition LLC dba Tailor Made Compounding
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 200 Moore Dr, Nicholasville, Kentucky 40356-8512
Distribution
- Quantity
- 1,562 vials
- Distribution pattern
- Nationwide USA and Puerto Rico
Timeline
- Recall initiated
- 2022-03-07
- FDA classified
- 2022-07-14
- Posted by FDA
- 2022-07-20
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-1227-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.