PlainRecordsFDA · Drug recall
Enalapril Maleate Tablet…
- Date
- Sept. 26, 2012
- Risk class
- Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)
- Status
- Terminated
- Filed by
- Apace KY LLC
- Product
- Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30
- Reason
- Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.
- Distribution pattern
- Nationwide
- Quantity
- 81,516 bottles
- Codes and lots
- Lot: DL11600 Exp Date: 06/13
- Recall started
- Sept. 4, 2012
- Recall number
- D-1683-2012
What should I do? Medicine recall: what to do
Source: FDA · Drug enforcement report, recall number D-1683-2012. The agency record governs; check it and the company before acting.