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.
Product description
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.
Lot numbers, UPCs & expiration codes
Outer Cases and Cartons Lot #: 13650, EXP 06/2017; Blisters Lot #: 13560, EXP 06/2017
Where it was sold
All product was shipped to KY and further distributed Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0811-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 12, 2016
- FDA report date
- Apr 13, 2016
- Quantity
- 291 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apace KY LLC
Original FDA data
Every field from FDA enforcement report D-0811-2016, exactly as published.
Show all FDA fields
- City
- Fountain Run
- State
- KY
- Status
- Terminated
- Country
- United States
- Event ID
- 73326
- Address
- 12954 Fountain Run Rd
- Code information
- Outer Cases and Cartons Lot #: 13650, EXP 06/2017; Blisters Lot #: 13560, EXP 06/2017
- Postal code
- 42133-7914
- Report date
- Apr 13, 2016
- Product type
- Drugs
- Recall number
- D-0811-2016
- Classification
- Class III
- Recalling firm
- Apace KY LLC
- Product quantity
- 291 cartons
- Termination date
- Aug 22, 2016
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- All product was shipped to KY and further distributed Nationwide
- Recall initiation date
- Feb 12, 2016
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Apr 5, 2016