Drug recall: Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30
Class III FDA enforcement event 63080. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.
Class III, in the words of FDA
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
Apace KY LLC started this drug recall on 4 Sep 2012. The firm address in the FDA record is in Fountain Run, KY. FDA put the recall in Class III. FDA event 63080 has 1 product record. The first FDA enforcement report date is 26 Sep 2012. The record gives the status Terminated, with the termination date 10 Jul 2013.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide
Recalling firm
Apace KY LLC, Fountain Run, KY.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1683-2012 | Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30 | 81,516 bottles | Class III | Terminated | 26 Sep 2012 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class III: The lowest of the three FDA recall classes.
The event in context
- Drug events that started in 2012
- 209
- Share of these events in Class III
- 28%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 4
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 9 Feb 2018 | Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 50268-061-11] per carton [NDC 50268-061-15], | Drug | Class II | 1 |
| 19 Jun 2017 | Amantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5x10) Unit Dose Cartons, Manufactured for: AvKARE Inc, Pulas | Drug | Class II | 2 |
| 12 Feb 2016 | Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Dose blisters (NDC 50268-569-11, barcode 5026 | Drug | Class III | 1 |
Official channels
- FDA enforcement report D-1683-2012The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 63080. https://recallregister.com/fda/iii/63080/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide
- What quantity of product is in FDA event 63080?
- The FDA record gives this quantity:
81,516 bottles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2012 have the same class?
- 28% of the 209 drug events that started in 2012 are in Class III.