Drug product
ATROPINE SULFATE/DIPHENOXYLATE HCL, Tablet, 0.025 mg/2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378041501.
D-891-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 300 Tablets
- Official record key
drug-enforcement:D-891-2014
Official wording
Reason: Labeling: Label Mixup: ATROPINE SULFATE/DIPHENOXYLATE HCL, Tablet, 0.025 mg/2.5 mg may have potentially been mislabeled as the following drug: CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00536355601, Pedigree: AD65475_25, EXP: 5/28/2014. TRI-BUFFERED ASPIRIN, Tablet, 325 mg, NDC 00904201559, Pedigree: W003581, EXP: 6/24/2014.
Code information: ATROPINE SULFATE/DIPHENOXYLATE HCL, Tablet, 0.025 mg/2.5 mg has the following codes: Pedigree: AD65475_13, EXP: 5/28/2014; Pedigree: W003597, EXP: 6/24/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled