Recalls / Class II
Class IID-0293-2017
Product
Sermorelin Forte Plus 27 mg (Sermorelin Acetate 9 mg/GHRP-6 9 mg/GHRP-2 9 mg). Compounded by Tri-Coast Pharmacy
- Affected lot / code info
- Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05252016B (11/21/2016), 06232016B (12/20/2016), 07152016B (01/11/2017), 08262016D (01/30/2017), 08152016A (01/30/2017), 08022016C (01/29/2017), 09282016C (03/27/2017), 10192016C (04/17/2016), 10252016B (04/23/2017).
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Tri-Coast Pharmacy
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 14125 US Highway 1, N/A, Juno Beach, Florida 33408-1425
Distribution
- Quantity
- 2116 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-11-17
- FDA classified
- 2017-01-04
- Posted by FDA
- 2017-01-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0293-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.