Recalls / Class II
Class IID-1155-2018
Product
Ipamorelin 9 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
- Affected lot / code info
- Lots: IPA9-15 Exp. 3/31/2019; IPA9-14 Exp. 1/31/2019
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
- 599 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-1155-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.