Perry Drug Recalls Tri-Mix Vials Due to Sterility Assurance Concerns
Perry Drug Inc. is recalling 17 vials of compounded Tri-Mix in Kansas and Missouri due to quality control issues affecting 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant risks such as sterility assurance failures in sterile products are categorized as Severe.
Plain-English summary
Perry Drug Inc. is recalling 17 vials of Tri-Mix (PGE-10MCG/PAP-30MG/PT 5Ml vials, Compounded Rx, NDC 88888-5123-09). The affected products were distributed in Kansas and Missouri.
The recall was initiated due to concerns associated with quality control procedures that present a potential risk to sterility assurance. These concerns were observed during a recent FDA inspection. All lots of sterile products compounded by the pharmacy that are within expiry were recalled.
Consumers should stop using the affected vials and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Tri-Mix (PGE-10MCG/PAP-30MG/PT 5Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5123-09
- Manufacturer
- Perry Drug Inc.
- Category
- Drug — Compounded Prescription
- Hazard
- Affected units
- 17
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 (20)
- 141008BB
- 11/8/14
- 141008CC
- 141010G
- 11/10/14
- 141010J
- 141010K
- 141013GG
- 11/13/14
- 141015DD
- 11/15/14
- 141015BB
- 141020GG
- 11/20/14
- 141024HH
- 11/24/14
- 141024II
- 141024JJ
- 141028BB
- 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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