Abbott's Compounding Pharmacy Recalls Sterile Compounded Products for Sterility Concerns
Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns regarding lack of 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 classification is FDA Class II. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as lack of sterility assurance in sterile products) are classified as Severe (Score 4), as they are not explicitly Class I but represent a significant risk.
Plain-English summary
Abbott's Compounding Pharmacy, Inc. is recalling all unexpired lots of sterile compounded products. The recall was initiated after an FDA inspection identified concerns regarding the lack of sterility assurance for these products.
The specific product involved is a compounded prescription containing papaverine, phentolamine, and prostaglandin (12/1 mg/30 mcg/mL) in 10 mL units. The products were distributed in California. The recall covers all lots of this specific compounded product.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- papaverine phentolamine prostaglandin; 12/1 mg/30 mcg/mL; 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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