Drug product
GLYCOPYRROLATE, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603318121.
D-983-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1300 Tablets
- Official record key
drug-enforcement:D-983-2014
Official wording
Reason: Labeling: Label Mixup: GLYCOPYRROLATE, Tablet, 2 mg may have potentially been mislabeled as one of the following drugs: PARICALCITOL, Capsule, 1 mcg, NDC 00074431730, Pedigree: W002667, EXP: 6/5/2014; guaiFENesin ER, Tablet, 600 mg, NDC 63824000850, Pedigree: W003244, EXP: 6/17/2014; LACTOBACILLUS, Tablet, 0, NDC 64980012950, Pedigree: AD22865_1, EXP: 5/2/2014.
Code information: GLYCOPYRROLATE, Tablet, 2 mg has the following codes: Pedigree: W002650, 6/5/2014; Pedigree: W003252, 6/17/2014; Pedigree: AD22865_4, 5/2/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled