FDA recall D-0811-2016

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.

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

Key facts

Status

Terminated

Initiation date

2016-02-12

Report date

2016-04-13

Termination date

2016-08-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fountain Run, KY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0811-2016