Minocycline Hydrochloride Capsules USP…

Date

April 13, 2016

Risk class

Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)

Status

Terminated

Filed by

Apace KY LLC

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

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

Quantity

291 cartons

Codes and lots

Outer Cases and Cartons Lot #: 13650, EXP 06/2017; Blisters Lot #: 13560, EXP 06/2017

Recall started

Feb. 12, 2016

Recall number

D-0811-2016

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-0811-2016. The agency record governs; check it and the company before acting.