The Recall Desk
SevereFDA (Drugs)·D-0452-2019·Announced 2019-02-20

Promise Pharmacy Recalls Ipamorelin Injection Due to Sterility Concerns

Promise Pharmacy is recalling 927 vials of Ipamorelin+Modified GRF 1-29 injection because of a lack of sterility assurance.

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, which corresponds to a Severe rating under the rubric for significant injury or property damage reports, or high-risk contamination.

Plain-English summary

Promise Pharmacy, LLC is recalling 927 vials of Ipamorelin+Modified GRF 1-29, 9 mg/5mg injection. The product was distributed nationwide in the USA. The recall was initiated due to a lack of sterility assurance.

The affected lots are 07052018@1, 09182018@6, 09212018@10, 10052018@1, and 11062018@2. The expiration dates for these lots range from January 1, 2019, to April 19, 2019.

Consumers should stop using the product and contact their healthcare provider or the pharmacy for further instructions.

The recalled product

Product
Ipamorelin+Modified GRF 1-29, 9 mg/5mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Manufacturer
Promise Pharmacy, LLC
Category
Drug — Injectable Compounded Drug
Hazard
Affected units
927

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 (5)

  • Lots: 07052018@1 BUD: 1/1/2019
  • 09182018@6 BUD: 3/1/2019
  • 09212018@10 BUD: 3/4/2019
  • 10052018@1 BUD: 3/18/2019
  • 11062018@2 BUD: 4/19/2019

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 →

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Same hazard · sterility

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