Abbott's Compounding Pharmacy Recalls Papaverine Phent Due to Sterility Concerns
Abbott's Compounding Pharmacy is recalling all unexpired lots of papaverine phent sterile compounded products because an FDA inspection found concerns regarding the assurance of sterility.
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 lack of sterility assurance in a sterile compounded product, which poses a risk of serious injury or death from infection, meeting the criteria for a Severe rating.
Plain-English summary
Abbott's Compounding Pharmacy, Inc. is recalling all unexpired lots of papaverine phent, 25 mg/0.833 mg/mL, 20 mL unit size. The product is a sterile compounded prescription medication distributed in California.
The recall was initiated after an FDA inspection identified concerns regarding the lack of assurance of sterility for the sterile compounded products. The agency classification for this recall is Class II.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- papaverine phent, 25 mg/0.833 mg/mL, 20 mL unit size Refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
- Manufacturer
- Abbott's Compounding Pharmacy, Inc.
- Hazard
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 (1)
- All lots
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 43 recalled by Abbott's Compounding Pharmacy, 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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