Recalls / Class III

Class IIID-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.

Affected lot / code info

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

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.

Recalling firm

Firm

Apace KY LLC

Notification channel

Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Type

Voluntary: Firm initiated

Address

12954 Fountain Run Rd, N/A, Fountain Run, Kentucky 42133-7914

Distribution

Quantity

291 cartons

Distribution pattern

All product was shipped to KY and further distributed Nationwide

Timeline

Recall initiated

2016-02-12

FDA classified

2016-04-05

Posted by FDA

2016-04-13

Terminated

2016-08-22

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0811-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.