Apace KY LLC
Apace KY LLC has 4 FDA enforcement events on this register (5 product records) between 2012 and 2018: 4 drug; the busiest year was 2012 with 1.
0% of its events are Class I; the most common class is Class II (2). 0 events are listed as ongoing; the recalling firm's address is in KY.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 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], Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478 | Drug | Class II | 1 | Terminated |
| 19 Jun 2017 | Amantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5x10) Unit Dose Cartons, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0069-15 | Drug | Class II | 2 | Terminated |
| 12 Feb 2016 | Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Dose blisters (NDC 50268-569-11, barcode 5026856911) per carton (NDC 50268-569-13, barcode 5026856913), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. | Drug | Class III | 1 | Terminated |
| 4 Sep 2012 | Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30 | Drug | Class III | 1 | Terminated |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Apace KY LLC had?
4 enforcement events (5 product records) on this register, 2012–2018: 4 drug.
Are any Apace KY LLC recalls ongoing?
0 events are listed as ongoing in the current openFDA export.
What class are Apace KY LLC recalls?
2 Class II, 2 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.