Abbott's Compounding Pharmacy Recalls Sterile Compounded Papaverine Phentolamine Products
Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded papaverine phentolamine products due to concerns about lack of sterility assurance 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. According to the rubric, FDA Class II recalls with potential for serious injury or hospitalization (implied by lack of sterility assurance in sterile products) fall under the Severe category.
Plain-English summary
Abbott's Compounding Pharmacy, Inc. is recalling all unexpired lots of sterile compounded papaverine phentolamine 30 mg/1mg/mL products. The affected products are available in 5 mL and 10 mL unit sizes and are distributed in California.
The recall was initiated after an FDA inspection identified concerns regarding the lack of sterility assurance for these sterile compounded products. The source text does not specify the number of units affected or report any illnesses or injuries.
Consumers and healthcare providers should stop using the affected products and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- papaverine phentolamine 30 mg/1mg/mL, 5 mL and 10 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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