FDA-Drug2016-04-13Class III
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.
Apace KY LLC
Hazard
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.
Sold states
All product was shipped to KY and further distributed Nationwide
Affected count
291 cartons
Manufactured in
12954 Fountain Run Rd, N/A, Fountain Run, KY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0811-2016Don't want to check this manually?
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