The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1147-2018·Announced 2018-09-05

Pharmcore Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns

Pharmcore Inc. is recalling 5,718 vials of Human Chorionic Gonadotropin 5000 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 rating under the rubric for drug recalls involving potential serious health consequences.

Plain-English summary

Pharmcore Inc. is recalling 5,718 vials of Human Chorionic Gonadotropin 5000 IU 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 March 31, 2019, to April 30, 2019. The lot numbers involved are HCG50309, HCG50310, HCG50311, HCG50313, HCG50314, HCG50315, HCG50316, HCG50317, HCG50318, HCG50319, HCG50320, and HCG50321.

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

The recalled product

Product
Human Chorionic Gonadotropin 5000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Manufacturer
Pharmcore Inc.
Category
Drug — Injectable Medication
Hazard
Affected units
5,718

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 (12)

  • Lots: HCG50319 Exp. 4/30/2019
  • HCG50316 Exp. 3/31/2019
  • HCG50317 Exp. 4/30/2019
  • HCG50315 Exp. 3/31/2019
  • HCG50318 Exp. 4/30/2019
  • HCG50320 Exp. 4/30/2019
  • HCG50321 Exp. 4/30/2019
  • HCG50311 Exp. 3/31/2019
  • HCG50310 Exp. 3/31/2019
  • HCG50309 Exp. 3/31/2019
  • HCG50313 Exp. 3/31/2019
  • HCG50314 Exp. 3/31/2019

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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