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.
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 structural defects, are rated as Severe (4). While no injuries are explicitly reported in the text, the lack of sterility assurance in sterile compounded products poses a significant risk of serious harm, aligning with the Severe criteria for high-risk contamination without confirmed fatalities.
Plain-English summary
Abbott's Compounding Pharmacy, Inc. is recalling all unexpired lots of sterile compounded products, specifically papaverine phentolamine prostaglandin (12/0.83 mg/10 mcg/ml) in 5 mL and 10 mL units. The recall is being conducted because an FDA inspection identified concerns regarding the lack of assurance of sterility for these products.
The recall covers all lots of the affected sterile compounded products. The distribution pattern is listed as California (CA). The source text does not specify the exact number of units recalled or the specific dates of distribution.
Consumers and healthcare providers should stop using the recalled products and contact their pharmacist or the recalling firm for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- papaverine phentolamine prostaglandin; 12/0.83 mg/10 mcg/ml; 5 mL and 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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