Recalls / Class I
Class ID-0918-2017
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Human Chorionic Gonadotropin, 15,000 IU per vial, lyophilized for injection, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014
- Affected lot / code info
- Lot # 22016, Exp 1/30/2017
Why it was recalled
Non-sterility - presence of bacteria confirmed by outside laboratory after day 14.
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
- 49 vials
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-04-02
- FDA classified
- 2017-06-13
- Posted by FDA
- 2017-06-21
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0918-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.