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 lack of sterility assurance found during an FDA inspection.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or in this case, a critical sterility failure in a sterile product which poses a high risk of serious harm, align with the 'Severe' category (Score 4).
Plain-English summary
Abbott's Compounding Pharmacy, Inc. is recalling all unexpired lots of sterile compounded products, specifically papaverine phentolamine prostaglandin in 5 mL and 10 mL unit sizes. The recall was initiated after an FDA inspection identified concerns regarding the lack of sterility assurance for these products.
The affected products were distributed in California. The recall covers all lots of the specified sterile compounded products.
Consumers and healthcare providers should stop using these products and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- papaverine phentolamine prostaglandin; 12/1 mg/10 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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