papaverine phentolamine prostaglandin — Class II drug recall D-0697-2016
Terminated recall by Abbott's Compounding Pharmacy, Inc., reported 2016-02-24, distributed in CA. Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA
| Recall number | D-0697-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott's Compounding Pharmacy, Inc., Berkeley, CA, United States |
| Recall initiated | 2016-01-15 |
| Classified | 2016-02-17 |
| Reported by FDA | 2016-02-24 |
| Terminated | 2017-04-06 |
| Distributed | CA |
| Quantity | 10 ml |
| Reason classes | sterility |
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
Reason for recall
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0697-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.