Perry Drug Recalls Tri-mix Antidote Syringes Due to Sterility Concerns
Perry Drug Inc. is recalling Tri-mix Antidote syringes in Kansas and Missouri due to potential sterility assurance issues identified during an FDA inspection.
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 compounded products, which poses a significant risk of serious injury or infection, fitting the 'Severe' criteria for significant injury reports or high-risk defects.
Plain-English summary
Perry Drug Inc. is recalling Tri-mix Antidote 10 each Syringes (NDC 88888-0205-17) compounded by Perry Drug Compounding Pharmacy in Overland Park, Kansas. The recall covers 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 that present a potential risk to sterility assurance. These concerns were observed during a recent FDA inspection. The affected products were distributed in Kansas and Missouri.
Consumers and healthcare providers should stop using the recalled syringes and contact their pharmacist or the recalling firm for further instructions on disposal or replacement.
The recalled product
- Product
- Tri-mix Antidote 10 each Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0205-17
- Manufacturer
- Perry Drug Inc.
- Affected units
- 10
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)
- 141010K
- 11/10/14
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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