Recalls / Class II
Class IID-0237-2021
Product
HUMAN CHORIONIC GONADOTROPIN 1,250 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035
- Affected lot / code info
- Lot #: 40548, Use By Date, 01/30/2021.
Why it was recalled
CGMP deviations: Lack of potency testing.
Recalling firm
- Firm
- Complete Pharmacy and Medical Solutions, LLC.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 5829 Nw 158th St, N/A, Miami Lakes, Florida 33014-6721
Distribution
- Quantity
- 2400 vials
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2020-11-20
- FDA classified
- 2021-01-19
- Posted by FDA
- 2021-01-27
- Terminated
- 2022-09-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0237-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.