D-1155-2018 Class II Terminated
FDA drug recall D-1155-2018 was initiated by Pharmcore Inc. on August 2, 2018 and is designated Class II. Reason for recall: Lack of assurance of sterility. The recall status is terminated (terminated January 18, 2022). Affected quantity: 599 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- September 5, 2018
- Initiation Date
- August 2, 2018
- Termination Date
- January 18, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 599 vials
Product Description
Ipamorelin 9 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Reason for Recall
Lack of assurance of sterility.
Distribution Pattern
Nationwide
Code Information
Lots: IPA9-15 Exp. 3/31/2019; IPA9-14 Exp. 1/31/2019