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 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 drugs) where a lack of sterility assurance poses a potential infection risk, but no injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
Abbott's Compounding Pharmacy, Inc. is recalling all unexpired lots of sterile compounded products. The recall includes the specific product papaverine phentolamine prostaglandin (18/0.6 mg/6 mcg/mL, 10 mL unit size). The recall was initiated after 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 who have these products should stop using them and contact their healthcare provider or the recalling firm for further instructions. The FDA has not reported any illnesses or injuries associated with this recall in the provided text.
The recalled product
- Product
- papaverine phentolamine prostaglandin; 18/0.6 mg/6 mcg/mL; 10 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.
See all 43 products in this recall →Related recalls
Same manufacturer · Abbott's Compounding Pharmacy, Inc.
See all →- HighAbbott's Compounding Pharmacy Recalls Methylcobalamine Due to Sterility Concerns
FDA (Drugs) · 2016-02-24
- SevereAbbott's Compounding Pharmacy Recalls Sterile Compounded Papaverine Phentolamine Products
FDA (Drugs) · 2016-02-24
- SevereAbbott's Compounding Pharmacy Recalls Sterile Compounded Products Due to Sterility Concerns
FDA (Drugs) · 2016-02-24
- SevereAbbott's Compounding Pharmacy Recalls Sterile Compounded Products for Sterility Concerns
FDA (Drugs) · 2016-02-24
- SevereAbbott's Compounding Pharmacy Recalls Sterile Hydroxyprogesterone Due to Sterility Concerns
FDA (Drugs) · 2016-02-24
Same hazard · lack of sterility
See all →- SevereK.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
- SevereGentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
Similar recalls
- HighCompounded Injectable Drug Recalled Due to Sterility Assurance Defect
FDA (Drugs) · 2022-11-09
- HighPharmacy Compounded Injection Recalled for Sterility Assurance Failure
FDA (Drugs) · 2022-11-09
- SevereThe Apothecary Recalls Sterile Medications Due to Sterility Assurance Issues
FDA (Drugs) · 2016-09-28
- SevereFDA Recalls Papaverine Injectable Due to Sterility Assurance Concerns
FDA (Drugs) · 2014-11-12
- SevereFDA Recalls Injectable Solution Due to Lack of Sterility Assurance
FDA (Drugs) · 2015-11-04
- SevereFDA Recalls Compounded Injectable Drug Due to Sterility Concerns
FDA (Drugs) · 2014-11-12