Drug product
GLYCOPYRROLATE Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 49884006601
D-586-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-586-2014
Official wording
Reason: Labeling: Label Mixup; GLYCOPYRROLATE Tablet, 2 mg may be potentially mislabeled as LACTOBACILLUS, Tablet, NDC 64980012950, Pedigree: W003624, EXP: 1/31/2014.
Code information: GLYCOPYRROLATE, Tablet, 2 mg has the following code Pedigree: W003625, EXP: 6/25/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled