The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1152-2018·Announced 2018-09-05

Pharmcore Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns

Pharmcore Inc. is recalling 3,351 vials of Human Chorionic Gonadotropin 6000 IU 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk scenarios.

Plain-English summary

Pharmcore Inc. is recalling 3,351 vials of Human Chorionic Gonadotropin 6000 IU Vial Lyophilized. The recall was initiated because of a lack of assurance of sterility for the product.

The affected product is distributed nationwide. The recall includes specific lots with expiration dates ranging from January 31, 2019, to June 30, 2019. The lots involved are HCG60122, HCG60124, HCG60121, HCG60123, HCG60120, HCG60118, and HCG1115.

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

The recalled product

Product
Human Chorionic Gonadotropin 6000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Manufacturer
Pharmcore Inc.
Category
Drug — Injectable Medication
Hazard
Affected units
3,351

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 (7)

  • Lots: HCG60122 Exp. 4/30/2019
  • HCG60124 Exp. 6/30/2019
  • HCG60121 Exp. 4/30/2019
  • HCG60123 Exp. 5/31/2019
  • HCG60120 Exp. 4/30/2019
  • HCG60118 Exp. 2/28/2019
  • HCG1115 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 →

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