Perry Drug Recalls Sodium Tetradecyl Sulfate Injections Due to Sterility Concerns
Perry Drug Inc. is recalling 20 vials of compounded Sodium Tetradecyl Sulfate 0.3% Injection in Kansas and Missouri due to potential sterility assurance issues found 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 recall is classified as FDA Class II and involves a potential risk to sterility assurance in sterile injectable products, which aligns with the rubric criteria for Severe severity (FDA Class II with significant risk).
Plain-English summary
Perry Drug Inc. is recalling 20 vials of Sodium Tetradecyl Sulfate 0.3% Injection, 30 Ml vials, compounded by Perry Drug Compounding Pharmacy in Overland Park, Kansas. The product is identified by NDC 88888-6427-90 and lot code 141030FF with an expiration date of 11/30/14. 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 agency has classified this as a Class II recall.
The affected products were distributed in Kansas and Missouri. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Sodium Tetradecyl SO4 0.3% Inj., 30 Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-6427-90
- Manufacturer
- Perry Drug Inc.
- 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 (2)
- 141030FF
- 11/30/14
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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