The Recall Desk
SevereFDA (Drugs)·D-0463-2019·Announced 2019-02-20

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
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.

See all 51 products in this recall →