ePHEDrine Sulfate Injection — Class II drug recall D-1548-2014
Terminated recall by US Compounding Inc, reported 2014-08-27, distributed nationwide. Labeling: Label Error on Declared Strength; The outer light protective bags, where the ephedrine sulfate injec
| Recall number | D-1548-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | US Compounding Inc, Conway, AR, United States |
| Recall initiated | 2014-05-16 |
| Classified | 2014-08-20 |
| Reported by FDA | 2014-08-27 |
| Terminated | 2014-11-04 |
| Distributed | Nationwide (US) |
| Quantity | 762 syringes |
| Reason classes | labeling, potency |
| NDC | 62295-3084-05 |
| Expiration dates | 2014-10-18 |
Product
ePHEDrine Sulfate Injection, USP 25 mg/5 mL (5 mg/mL) Single Use 5 mL Syringe, For IV, IM, or SC injection, Preservative Free, For Office/Hospital Use Only, Protect from Light, 62295-3084-05, US Compounding Pharmacy, Conway, AR 800-718-3588
Reason for recall
Labeling: Label Error on Declared Strength; The outer light protective bags, where the ephedrine sulfate injection syringes are stored, were mislabeled with 25 mg/mL in big font and 5 mg/mL in small font, however, the actual syringes were correctly labeled as 25 mg/5 mL.
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-1548-2014. 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.