Drug product
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.
D-0811-2016
Product summary
- Firm
- Apace KY LLC
- Event
- Event 73326
- Status
- Terminated
- Classification
- Class III
- Quantity
- 291 cartons
- Official record key
drug-enforcement:D-0811-2016
Official wording
Reason: 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.
Code information: Outer Cases and Cartons Lot #: 13650, EXP 06/2017; Blisters Lot #: 13560, EXP 06/2017
Distribution pattern: All product was shipped to KY and further distributed Nationwide
Derived failure modes
-
Labeling or packaging
mislabeled