D-1683-2012 Class III Terminated
FDA drug recall D-1683-2012 was initiated by Apace KY LLC on September 4, 2012 and is designated Class III. Reason for recall: Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength. The recall status is terminated (terminated July 10, 2013). Affected quantity: 81,516 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 26, 2012
- Initiation Date
- September 4, 2012
- Termination Date
- July 10, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 81,516 bottles
Product Description
Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30
Reason for Recall
Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.
Distribution Pattern
Nationwide
Code Information
Lot: DL11600 Exp Date: 06/13