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 because 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 recall is classified as FDA Class II, and the hazard involves a lack of sterility assurance in sterile compounded products, which poses a significant risk of serious injury or infection.
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 assurance of sterility for these products.
The affected products include papaverine phentolamine prostaglandin (12/1 mg/9 mcg/mL) in 5 mL and 10 mL unit sizes. These are prescription compounded products that must be refrigerated. The recall covers all lots of these sterile compounded products.
Consumers and healthcare providers should stop using the affected products and contact their healthcare provider or pharmacist for further instructions. The recall is limited to products distributed in California.
The recalled product
- Product
- papaverine phentolamine prostaglandin; 12/1 mg/9 mcg/mL; 5 mL and 10 mL unit sizes, 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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