Pharmcore Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns
Pharmcore Inc. is recalling 355 vials of Human Chorionic Gonadotropin 20000 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, and the rubric specifies that FDA Class II recalls with potential for serious injury or hospitalization (implied by sterility failure in injectable drugs) fall under the Severe category.
Plain-English summary
Pharmcore Inc. is recalling 355 vials of Human Chorionic Gonadotropin 20000 IU Vial Lyophilized. The recall is being conducted because of a lack of assurance of sterility for the product.
The affected product includes lots HCG22038 (expiration date 3/31/2019) and HCG22039 (expiration date 4/30/2019). The product was distributed nationwide.
Consumers and healthcare providers should stop using the recalled product and contact Pharmcore Inc. for further instructions.
The recalled product
- Product
- Human Chorionic Gonadotropin 20000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
- Manufacturer
- Pharmcore Inc.
- Category
- Drug — Injectable
- Hazard
- Affected units
- 355
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: HCG22038 Exp. 3/31/2019
- HCG22039 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 →Related recalls
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