FDA Drug Recalls

Recalls / Class II

Class IID-0295-2017

Product

Slim Shot (Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50mg/Methylcobalamin 1 mg/Pyridoxine HCL 2.2mg/ml), (30 ML). 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): 06292016A (12/26/2016), 08102016C (01/31/2017), 10262016C (02/28/2017).

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
127 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-0295-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls