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, including papaverine phentolamine, after FDA inspection found concerns regarding lack of sterility assurance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile compounded drugs) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Abbott's Compounding Pharmacy, Inc. is recalling all unexpired lots of sterile compounded products. The recall includes papaverine phentolamine, 35 mg/2.5 mg/mL, 5 mL unit size, which is compounded and requires refrigeration. The products were distributed in California.
The recall was initiated after an FDA inspection identified concerns regarding a lack of assurance of sterility for these sterile compounded products. The source text does not specify the exact number of units affected or specific lot numbers beyond stating that all unexpired lots are included.
Consumers who have these products should contact their healthcare provider or the pharmacy for further instructions on how to proceed. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- papaverine phentolamine, 35 mg/2.5 mg/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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