The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1148-2018·Announced 2018-09-05

Pharmcore Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns

Pharmcore Inc. is recalling 864 vials of Human Chorionic Gonadotropin 11000 IU due to a lack of assurance of sterility. The affected lots were distributed 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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the lack of sterility assurance in a drug product is a significant safety concern that aligns with the Severe classification for Class II recalls.

Plain-English summary

Pharmcore Inc. is recalling 864 vials of Human Chorionic Gonadotropin 11000 IU Vial Lyophilized. The recall was initiated because of a lack of assurance of sterility in the product.

The affected product includes lots HCG1116 with an expiration date of 3/31/2019 and HCG1117 with an expiration date of 4/30/2019. These vials were distributed nationwide.

Consumers and healthcare providers should stop using the affected vials and contact Pharmcore Inc. or their healthcare provider for instructions on how to return or dispose of the product.

The recalled product

Product
Human Chorionic Gonadotropin 11000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Manufacturer
Pharmcore Inc.
Category
Drug — Injectable
Hazard
Affected units
864

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: HCG1116 Exp. 3/31/2019
  • HCG1117 Exp. 4/30/2019

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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