Promethazine 6 — Class II drug recall D-1273-2016
Terminated recall by Pharmakon Pharmaceuticals, Inc., reported 2016-07-20, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-1273-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pharmakon Pharmaceuticals, Inc., Noblesville, IN, United States |
| Recall initiated | 2016-04-20 |
| Classified | 2016-07-11 |
| Reported by FDA | 2016-07-20 |
| Terminated | 2018-01-11 |
| Distributed | Nationwide (US) |
| Quantity | 40 |
| Reason classes | sterility |
| NDC | 45183-0177-41 |
Product
Promethazine 6.25 mg added to 0.9% Sodium Chloride 50 mL in 100 mL B/Braun PAB bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0177-41
Reason for recall
Lack of Assurance of Sterility
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-1273-2016. 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.