Recalls / Class II
Class IID-1399-2019
Product
Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc.
- Affected lot / code info
- All lots remaining within expiry.
Why it was recalled
Lack of Processing Controls.
Recalling firm
- Firm
- Synthetopes Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 216 Earnhardt St, N/A, Conway, South Carolina 29526-8287
Distribution
- Quantity
- 20 vials
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2019-05-28
- FDA classified
- 2019-06-20
- Posted by FDA
- 2019-06-19
- Terminated
- 2020-10-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1399-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.