The Recall Desk
SevereFDA (Drugs)·D-1153-2018·Announced 2018-09-05

Pharmcore Recalls Ipamorelin Vials Due to Sterility Assurance Concerns

Pharmcore Inc. is recalling Ipamorelin 3 mg vials because the company cannot ensure the product is sterile.

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 severity score under the rubric for drug recalls with potential for temporary or medically reversible health consequences.

Plain-English summary

Pharmcore Inc. is recalling Ipamorelin 3 mg Lyophilized 1 vial products. The recall is being conducted because the company lacks assurance of the sterility of the product.

The affected product is identified by Lot IPA3-17 with an expiration date of 07/2018. The recall covers 6 vials and the product was distributed nationwide.

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

The recalled product

Product
Ipamorelin 3 mg Lyophilized 1 vial 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Manufacturer
Pharmcore Inc.
Category
Drug — Injectable
Hazard
Affected units
6

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 (1)

  • Lot: IPA3-17 Exp. 07/2018

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.

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Same hazard · sterility

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