Food, drugs, devices › Apace KY LLC
Drug recall: Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Dose blisters (NDC 50268-569-11, barcode 5026
Apace KY LLC (Fountain Run, KY) initiated this drug recall on 12 Feb 2016; FDA lists 1 product record under event 73326, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 43% of the 288 drug enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 22 Aug 2016. Initiation: voluntary: firm initiated. Apace KY LLC has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Apace KY LLC, Fountain Run, KY.
Reason for recall
"Labeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with an incorrect lot number of 13560 rather than the correct lot number of 13650."
Distribution
"All product was shipped to KY and further distributed Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0811-2016 | 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. | 291 cartons | Class III | Terminated | 13 Apr 2016 |
Context
Other enforcement events for Apace KY LLC
| 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 |
| 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 |
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Labeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with an incorrect lot number of 13560 rather than the correct lot number of 13650."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "All product was shipped to KY and further distributed Nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 22 Aug 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.