Abbott's Compounding Pharmacy Recalls Sterile Compounded Products for Sterility Concerns
Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products, including papaverine phentolamine prostaglandin, due to FDA inspection findings 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. The hazard involves a lack of sterility assurance in sterile compounded products, which poses a significant risk of infection or serious injury, fitting the 'Severe' criteria for significant injury reports or high-risk defects.
Plain-English summary
Abbott's Compounding Pharmacy, Inc. is recalling all unexpired lots of sterile compounded products. The recall includes the specific compounded prescription papaverine phentolamine prostaglandin (35/2.5 mg/1 mcg/mL, 10 mL). The products were distributed in California.
The recall was initiated after an FDA inspection identified concerns regarding a lack of assurance of sterility for the sterile compounded products. The source text does not specify the exact number of units recalled or the specific dates of distribution.
Consumers who have these products should stop using them and contact their healthcare provider or the pharmacy for further instructions. The source text does not report any illnesses or injuries associated with the use of these products.
The recalled product
- Product
- papaverine phentolamine prostaglandin; 35/2.5 mg/1 mcg/mL, 10 mL, unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
- Manufacturer
- Abbott's Compounding Pharmacy, Inc.
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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