Home / Recalls / Promise Pharmacy, LLC / D-0453-2019

D-0453-2019 Class II Terminated

Recalled by Promise Pharmacy, LLC — Palm Harbor, FL

FDA drug recall D-0453-2019 was initiated by Promise Pharmacy, LLC on Dec 17, 2018 and is designated Class II. Reason for recall: Lack of sterility assurance. The recall status is terminated (terminated Mar 30, 2021). Affected quantity: 416 vials.

Recall Details

Product Type: Drugs
Report Date: Feb 20, 2019
Initiation Date: Dec 17, 2018
Termination Date: Mar 30, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 416 vials

Product Description

Ipamorelin, 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

Reason for Recall

Lack of sterility assurance.

Distribution Pattern

Nationwide in the USA.

Code Information

Lots: 07132018@5 BUD: 1/9/2019; 07302018@32 BUD: 1/26/2019; 09182018@7 BUD: 3/17/2019; 10192018@2 BUD: 4/17/2019

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0453-2019
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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