Drug product
Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe, Total Volume 10 mL, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0600-12
D-0156-2018
Product summary
- Event
- Event 78708
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1248 syringes
- Official record key
drug-enforcement:D-0156-2018
Official wording
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and beyond use date.
Code information: Lot#: 20171013@30, Exp 12/27/2017
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing