Recalls / Class III
Class IIID-1683-2012
Product
Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30
- Affected lot / code info
- Lot: DL11600 Exp Date: 06/13
Why it was recalled
Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.
Recalling firm
- Firm
- Apace KY LLC
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 12954 Fountain Run Rd, Fountain Run, Kentucky 42133-7914
Distribution
- Quantity
- 81,516 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-09-04
- FDA classified
- 2012-09-19
- Posted by FDA
- 2012-09-26
- Terminated
- 2013-07-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1683-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.