Promise Pharmacy Recalls Ipamorelin Injections Due to Sterility Concerns
Promise Pharmacy is recalling 416 vials of Ipamorelin 9 mg injection because the product lacks sterility assurance. The affected lots were distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for serious injury (such as lack of sterility assurance in injectable drugs) are rated as Severe (4), particularly when no explicit 'no illness' statement is provided to cap the score at 3.
Plain-English summary
Promise Pharmacy, LLC is recalling 416 vials of Ipamorelin, 9 mg injection, Rx Only. The recall was initiated because the product lacks sterility assurance. The affected lots are 07132018@5, 07302018@32, 09182018@7, and 10192018@2, with expiration dates ranging from January 9, 2019, to April 17, 2019.
The recalled product was distributed nationwide in the United States. The source text does not specify the number of patients affected or report any illnesses or injuries associated with the use of these vials.
Consumers and healthcare providers should stop using the affected lots of Ipamorelin and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Ipamorelin, 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
- Manufacturer
- Promise Pharmacy, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 416
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 51 recalled by Promise Pharmacy, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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