The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1151-2018·Announced 2018-09-05

Pharmcore Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns

Pharmcore Inc. is recalling 2,085 vials of Human Chorionic Gonadotropin 4000 IU nationwide due to a lack of assurance of sterility.

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 FDA classified this recall as Class II. According to the rubric, an FDA Class II recall involving a significant risk of harm (lack of sterility assurance) without reported fatalities or hospitalizations is categorized as Severe.

Plain-English summary

Pharmcore Inc. is voluntarily recalling 2,085 vials of Human Chorionic Gonadotropin 4000 IU Vial Lyophilized. The recall is being conducted because the company lacks assurance of the sterility of the product. The affected product was distributed nationwide.

The recall includes specific lots with expiration dates ranging from February 28, 2019, to April 30, 2019. The lots involved are HCG40160, HCG40161, HCG40159, HCG40162, and HCG50308. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers who have purchased or received these specific lots of Human Chorionic Gonadotropin should stop using the product and contact Pharmcore Inc. or their healthcare provider for instructions on how to return the product or obtain a replacement.

The recalled product

Product
Human Chorionic Gonadotropin 4000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Manufacturer
Pharmcore Inc.
Category
Drug — Injectable
Hazard
Affected units
2,085

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: HCG40160 Exp. 2/28/2019
  • HCG40161 Exp. 4/30/2019
  • HCG40159 Exp. 2/28/2019
  • HCG40162 Exp. 4/30/2019
  • HCG50308 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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