FDAClass IIIApril 13, 2016

Minocycline Hydrochloride Capsules USP recall: Labeling Error

Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Dose blisters (NDC 50268-569-11, barcode 5026856911) per carton (NDC…

Why was Minocycline Hydrochloride Capsules USP 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Dose blisters (NDC 50268-569-11, barcode 5026856911) per carton (NDC…
Recalling firm
Apace KY LLC
Quantity
291 cartons
Distribution
All product was shipped to KY and further distributed Nationwide
Recall date
April 13, 2016
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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