Abbott's Compounding Pharmacy Recalls Sterile Compounded Products Due to Sterility Concerns
Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products after FDA inspection identified 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 source text explicitly states the agency classification is Class II. According to the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving sterile products where sterility assurance is compromised, posing a risk of infection.
Plain-English summary
Abbott's Compounding Pharmacy, Inc. is recalling all unexpired lots of sterile compounded products. The recall is being conducted after an FDA inspection identified concerns regarding the lack of assurance of sterility for these products.
The affected products include papaverine phentolamine prostaglandin (30/1.5 mg/40 mcg/mL) in 5 mL unit sizes. These are compounded prescription medications that must be refrigerated. The recall covers all lots of these sterile compounded products.
Consumers who have these products should stop using them 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; 30/1.5 mg/40 mcg/mL; 5 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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