Recalls / Class II
Class IID-0261-2017
Product
HCG 5,000 IU Vial. Compounded by Tri-Coast Pharmacy.
- Affected lot / code info
- Lot codes: 06222016D, 06062016C, 07192016C07062016A, 08182016B, 08112016A, 08012016A, 09282016A, 09122016D, 10182016C, 11042016B, 11012016F; Exp. 11/16
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
- 4,884 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-0261-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.