Drug product
PROPRANOLOL HCL Tablet, 5 mg (1/2 of 10 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 23155011001
D-530-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 198 Tablets
- Official record key
drug-enforcement:D-530-2014
Official wording
Reason: Labeling: Label Mixup; PROPRANOLOL HCL Tablet, 5 mg (1/2 of 10 mg) may be potentially mislabeled as LITHIUM CARBONATE ER, Tablet, 225 mg (1/2 of 450 mg), NDC 00054002025, Pedigree: AD73525_16, EXP: 5/30/2014.
Code information: PROPRANOLOL HCL, Tablet, 5 mg (1/2 of 10 mg) has the following code Pedigree: AD73525_25, EXP: 5/30/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled