Recalls / Class II
Class IID-1147-2018
Product
Human Chorionic Gonadotropin 5000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
- Affected lot / code info
- Lots: HCG50319 Exp. 4/30/2019; HCG50316 Exp. 3/31/2019; HCG50317 Exp. 4/30/2019; HCG50315 Exp. 3/31/2019; HCG50318 Exp. 4/30/2019; HCG50320 Exp. 4/30/2019; HCG50321 Exp. 4/30/2019; HCG50311 Exp. 3/31/2019; HCG50310 Exp. 3/31/2019; HCG50309 Exp. 3/31/2019; HCG50313 Exp. 3/31/2019; HCG50314 Exp. 3/31/2019;
Why it was recalled
Lack of assurance of sterility.
Recalling firm
- Firm
- Pharmcore Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1109 E Hallandale Beach Blvd, N/A, Hallandale Beach, Florida 33009-4431
Distribution
- Quantity
- 5718 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-08-02
- FDA classified
- 2018-08-28
- Posted by FDA
- 2018-09-05
- Terminated
- 2022-01-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1147-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.