Promise Pharmacy Recalls Sermorelin Injections Due to Sterility Concerns
Promise Pharmacy is recalling 266 vials of Sermorelin 15mg injections because they lack sterility assurance. The products 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 categorized as Severe.
Plain-English summary
Promise Pharmacy, LLC is recalling 266 vials of Sermorelin, 15mg, injection, Rx Only. The recall is being conducted because the products lack sterility assurance. The affected lots have expiration dates ranging from January 6, 2019, to May 5, 2019.
The recalled products were distributed nationwide in the USA. The source text does not specify the number of patients affected or report any illnesses or injuries associated with the use of these products.
Consumers who have these products should stop using them and contact their healthcare provider or pharmacist for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Sermorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
- Manufacturer
- Promise Pharmacy, LLC
- Hazard
- Affected units
- 266
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: 07102018@4 BUD: 1/6/2019
- 09142018@6 BUD: 3/13/2019
- 10052018@4 BUD: 4/3/2019
- 11062018@1 BUD: 5/5/2019
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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