HYDROmorphone HCl 50 mg/50 mL in 0 — Class II drug recall D-0195-2017
Terminated recall by Cantrell Drug Company, reported 2016-12-21, distributed nationwide. Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
| Recall number | D-0195-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cantrell Drug Company, Little Rock, AR, United States |
| Recall initiated | 2016-11-18 |
| Classified | 2016-12-13 |
| Reported by FDA | 2016-12-21 |
| Terminated | 2020-04-29 |
| Distributed | Nationwide (US) |
| Quantity | 935 syringes |
| Reason classes | sterility |
| NDC | 52533-0006-04 |
| Lot numbers | 9016 |
| Expiration dates | 2017-03-07 |
Product
HYDROmorphone HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-006-04
Reason for recall
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
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-0195-2017. 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.