Perry Drug Recalls Human Chorionic Gonadotropin Injections for Sterility Concerns
Perry Drug Inc. is recalling HCG injections due to quality control issues that may compromise sterility assurance.
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 agency classification is FDA Class II, and the hazard involves a lack of sterility assurance in sterile injectable products, which poses a significant risk of serious injury or infection.
Plain-English summary
Perry Drug Inc. is recalling 2Ml HCG 10,000 U/ MB12 - 12,000 MCG/10 Ml Inj, 0.25ML (250IU), Rx, manufactured by Perry Drug Compounding Pharmacy in Overland Park, KS. The recall affects all lots of sterile products compounded by the pharmacy that are within their expiration date.
The recall was initiated due to concerns regarding quality control procedures observed during a recent FDA inspection. These procedures present a potential risk to sterility assurance for the affected products.
The products were distributed in Kansas and Missouri. Consumers should check their inventory for the specific NDC 88888-7945-17 and lot code 141016A with an expiration date of 11/16/14. If you have this product, stop using it and contact your healthcare provider or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- 2Ml HCG 10,000 U/ MB12 - 12,000 MCG/10 Ml Inj, 0.25ML (250IU), Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-7945-17
- Manufacturer
- Perry Drug Inc.
- Affected units
- 1
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)
- 141016A
- 11/16/14
Distribution
Part of a larger recall action
This product is one of 17 recalled by Perry Drug 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.
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