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 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. The hazard involves a lack of sterility assurance in sterile compounded products, which poses a significant risk of serious injury or infection, fitting the criteria for a Severe rating.
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 in 5 mL and 10 mL unit sizes. The specific formulation is 22.5/0.83 mg/8.3 mcg/mL and requires refrigeration. These are prescription compounded products manufactured by Abbott's Compounding Pharmacy in Berkeley, CA.
Consumers and healthcare providers should stop using these products and contact their pharmacist or the recalling firm for further instructions. The recall covers all lots of the affected sterile compounded products.
The recalled product
- Product
- papaverine phentolamine prostaglandin; 22.5/0.83 mg/8.3 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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