D-0811-2016 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 13, 2016
- Initiation Date
- February 12, 2016
- Termination Date
- August 22, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 291 cartons
Product Description
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.
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 Pattern
All product was shipped to KY and further distributed Nationwide
Code Information
Outer Cases and Cartons Lot #: 13650, EXP 06/2017; Blisters Lot #: 13560, EXP 06/2017