Promise Pharmacy Recalls HCG Injections Due to Sterility Concerns
Promise Pharmacy is recalling 654 vials of HCG injections nationwide due to a lack of sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. 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, particularly given the risk of infection associated with non-sterile injections.
Plain-English summary
Promise Pharmacy, LLC is recalling 654 vials of HCG (Human chorionic gonadotropin) 11,000 units injection. The product is a prescription-only medication distributed nationwide in the United States.
The recall was initiated due to a lack of sterility assurance. The affected lots include 06182018@5, 07102018@5, and 08212018@8, with expiration dates ranging from January 6, 2018, to February 17, 2019.
Consumers who have purchased this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- HCG, Human chorionic gonadotropin 11,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
- Manufacturer
- Promise Pharmacy, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 654
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 (3)
- Lots: 06182018@5 BUD: 12/15/2018
- 07102018@5 BUD: 1/6/2018
- 08212018@8 BUD: 2/17/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 51 recalled by Promise Pharmacy, LLC 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.
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