Reported Apr 13, 2016 · Terminated
Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Dose blisters (NDC 50268-569-11, barcode…
Apace KY LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Apace KY LLC · 12954 Fountain Run Rd · Fountain Run, KY · 42133-7914
Is this the product you have?
- 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 forAvKARE, Inc., Pulaski, TN 38478
- Lot codes and dates
Outer Cases and Cartons Lot #: 13650EXP 06/2017Blisters Lot #: 13560EXP 06/2017
- Amount recalled
- 291 cartons
Where it was sold
- Nationwide
- KY
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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