Apace KY LLC Recalls Minocycline Capsules Due to Mislabeled Lot Numbers
Apace KY LLC is recalling 291 cartons of Minocycline Hydrochloride Capsules because individual blisters are mislabeled with an incorrect lot number.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a remote possibility of adverse health consequences. The issue is a labeling error regarding lot numbers, which is a documentation issue.
Plain-English summary
Apace KY LLC is voluntarily recalling 291 cartons of Minocycline Hydrochloride Capsules USP, 100 mg, 30 Capsules (3 x 10) Unit Dose blisters. The product is manufactured for AvKARE, Inc. and is available by prescription only.
The recall was initiated because the individual blisters are mislabeled with an incorrect lot number of 13560 rather than the correct lot number of 13650. The outer cases and cartons are correctly labeled with Lot # 13650 and an expiration date of 06/2017. The blisters are labeled with Lot # 13560 and an expiration date of 06/2017.
All product was shipped to Kentucky and further distributed nationwide. Consumers and healthcare providers should check their inventory for this specific product and stop using it if the blister lot number is 13560.
The recalled product
- 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.
- Manufacturer
- Apace KY LLC
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 291
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Outer Cases and Cartons Lot #: 13650
- EXP 06/2017
- Blisters Lot #: 13560
Distribution
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