Minocycline Hydrochloride Capsules USP recalled over labeling errors

Recall date

February 12, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Apace KY LLC recalls Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Dose blisters (NDC 50268-569-11, barcode 502…

Recall number

D-0811-2016

FDA classification

Class III

Brand / firm

Apace KY LLC

Sold / distributed

All product was shipped to KY and further distributed Nationwide

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.