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 prostaglandin, after FDA inspection found lack of sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medication) where injury has not yet been reported, and the agency classification is Class II, which aligns with the High severity criteria for theoretical hazards without reported illness.
Plain-English summary
Abbott's Compounding Pharmacy, Inc. is recalling all unexpired lots of sterile compounded products. The recall includes papaverine prostaglandin 30 mg/20 mcg/mL, 10 mL unit size, which is a compounded prescription medication requiring refrigeration. The products were distributed in California.
The recall was initiated after an FDA inspection identified concerns regarding the lack of assurance of sterility for these products. The firm is recalling all unexpired lots of sterile compounded products to address this issue.
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 specific illnesses or injuries associated with the use of these products.
The recalled product
- Product
- papaverine prostaglandin 30 mg/20 mcg/mL, 10 mL unit size; refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
- Manufacturer
- Abbott's Compounding Pharmacy, Inc.
- Category
- Drug — Compounded Prescription
- 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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