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.
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 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
- 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
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