Drug 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
D-1548-2014
Product summary
- Event
- Event 68336
- Status
- Terminated
- Classification
- Class II
- Quantity
- 762 Syringes
- Official record key
drug-enforcement:D-1548-2014
Official wording
Reason: 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.
Code information: Lot# 20142104@30 USE BY: 10/18/2014
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
mislabeled