The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1150-2018·Announced 2018-09-05

Pharmcore Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns

Pharmcore Inc. is recalling 3,070 vials of Human Chorionic Gonadotropin 2500 IU due to a lack of assurance of sterility. The recall is nationwide.

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 recall is classified as FDA Class II and involves a lack of assurance of sterility for an injectable drug, which poses a significant risk of infection and potential hospitalization.

Plain-English summary

Pharmcore Inc. is recalling 3,070 vials of Human Chorionic Gonadotropin 2500 IU Vial Lyophilized. The recall is being conducted because of a lack of assurance of sterility for the product.

The affected lots are HCG25112 (Exp. 2/28/2019), HCG25110 (Exp. 1/31/2019), HCG25115 (Exp. 4/30/2019), HCG25114 (Exp. 4/30/2019), and HCG25111 (Exp. 2/28/2019). The product was distributed nationwide.

Consumers and healthcare providers should stop using the recalled product and contact Pharmcore Inc. or their healthcare provider for further instructions.

The recalled product

Product
Human Chorionic Gonadotropin 2500 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Manufacturer
Pharmcore Inc.
Category
Drug — Injectable
Hazard
Affected units
3,070

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: HCG25112 Exp. 2/28/2019
  • HCG25110 Exp. 1/31/2019
  • HCG25115 Exp. 4/30/2019
  • HCG25114 Exp. 4/30/2019
  • HCG25111 Exp. 2/28/2019

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 →

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