Drug product
Glycopyrrolate injection, 0.2 mg per mL (1 mg/5 mL), 5 mL Fill in 10 mL Syringe, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, 877-550-5059
D-0339-2015
Product summary
- Event
- Event 70167
- Status
- Terminated
- Classification
- Class II
- Quantity
- 972 syringes
- Official record key
drug-enforcement:D-0339-2015
Official wording
Reason: Labeling: Incorrect or missing Lot and/or Exp Date: Printing error caused an overlap in the "y" and "3" making the actual "Use By 3/2015" date appear to read "Use By8/2015".
Code information: Lot #: 20141218@41, Use by 3/18/2015; 20141226@24, Use by 3/26/2015
Distribution pattern: Louisiana
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or missing