Drug product
Ipamorelin 9 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
D-1155-2018
Product summary
- Firm
- Pharmcore Inc.
- Event
- Event 80699
- Status
- Terminated
- Classification
- Class II
- Quantity
- 599 vials
- Official record key
drug-enforcement:D-1155-2018
Official wording
Reason: Lack of assurance of sterility.
Code information: Lots: IPA9-15 Exp. 3/31/2019; IPA9-14 Exp. 1/31/2019
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility