Drug product
Donnatal Extentabs, 0.3888mg/46.8mg, 100-count bottle (NDC # 66213-421-10), Rx only Manufactured By: West-ward Pharmaceutical, 435 Industrial Way West, Eatontown, NJ 07724 Manufactured For: PBM Pharmaceuticals, Inc. Gordonsville, VA 22942.
D-306-2013
Product summary
- Event
- Event 64753
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,258 bottles
- Official record key
drug-enforcement:D-306-2013
Official wording
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Bottled product is labeled with an expiration date of Apr 2015. The correct expiration is Apr 2013.
Code information: Lot # 68864; exp 04/13
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing