Pilocarpine — Class II drug recall D-0278-2016
Terminated recall by US Compounding Inc, reported 2015-11-25, distributed nationwide. Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to d
| Recall number | D-0278-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | US Compounding Inc, Conway, AR, United States |
| Recall initiated | 2015-09-12 |
| Classified | 2015-11-17 |
| Reported by FDA | 2015-11-25 |
| Terminated | 2017-03-30 |
| Distributed | Nationwide (US) |
| Quantity | 2 bottles |
| Reason classes | sterility |
| Expiration dates | 2015-09-12, 2015-11-29 |
Product
Pilocarpine (1/16%) Ophthalmic, 15 mL dropper bottle, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653
Reason for recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on 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-0278-2016. 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.