Perry Drug Recalls Tri Mix Syringes Due to Sterility Concerns
Perry Drug Inc. is recalling Tri Mix PF SYR 0.5 mL Inj. syringes in Kansas and Missouri due to potential sterility assurance risks identified during an FDA inspection.
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 source text explicitly identifies the agency classification as Class II. Per the rubric, FDA Class II recalls are mapped to a severity score of 4 (Severe), particularly given the risk to sterility assurance in injectable products.
Plain-English summary
Perry Drug Inc. is recalling 20 prefilled syringes of Tri Mix PF SYR 0.5 mL Inj. (NDC 88888-5036-49). The affected lots are 141021FF (dated 11/21/14) and 141028CC (dated 11/28/14). These compounded prescription products were distributed in Kansas and Missouri.
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 of the pharmacy. As a result, all lots of sterile products compounded by the pharmacy that are within their expiry date have been recalled.
Consumers who have these specific syringes should stop using them and contact their healthcare provider or the recalling firm for further instructions. The FDA classifies this recall as Class II.
The recalled product
- Product
- Tri Mix PF SYR 0.5 mL Inj., Compounded Rx, 10 each, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5036-49
- Manufacturer
- Perry Drug Inc.
- Category
- Drug — Compounded Prescription
- Affected units
- 20
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 (4)
- 141021FF
- 11/21/14
- 141028CC
- 11/28/14
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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