The Recall Desk
SevereFDA (Drugs)·D-1155-2018·Announced 2018-09-05

Pharmcore Recalls Ipamorelin Vials Due to Sterility Assurance Concerns

Pharmcore Inc. is recalling 599 vials of Ipamorelin 9 mg because the company cannot assure the sterility of the product.

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 agency classification is FDA Class II, and the hazard involves a lack of sterility assurance for an injectable drug, which poses a significant risk of infection or serious injury.

Plain-English summary

Pharmcore Inc. is voluntarily recalling 599 vials of Ipamorelin 9 mg Lyophilized. The recall is being conducted because the company lacks assurance of the sterility of the product.

The affected product includes lots IPA9-15 (expiration date 3/31/2019) and IPA9-14 (expiration date 1/31/2019). The product was distributed nationwide.

Consumers who have this product should stop using it and contact Pharmcore Inc. for further instructions or a refund.

The recalled product

Product
Ipamorelin 9 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Manufacturer
Pharmcore Inc.
Category
Drug — Injectable
Hazard
Affected units
599

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 (2)

  • Lots: IPA9-15 Exp. 3/31/2019
  • IPA9-14 Exp. 1/31/2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 9 recalled by Pharmcore Inc. 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 9 products in this recall →

Related recalls

Same manufacturer · Pharmcore Inc.

See all →

Same hazard · sterility

See all →