Why it was recalled
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Product description
Novolin 70/30, 100 Units/mL Solu., Qty: 1 Vial, MFG by: Novo Nordisk, A/S, Bagsvaerd, Denmark DK-2880, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 52125-0414-01
Lot numbers, UPCs & expiration codes
LOT#:QM114CZF0496, Exp 01/2016; B0025373-050514, B0029738-060914, Exp 02/2016; B0029737-060914, Exp 03/2016.
Where it was sold
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-0516-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 11, 2015
- FDA report date
- Dec 16, 2015
- Quantity
- 106 Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RemedyRepack Inc.
Original FDA data
Every field from FDA enforcement report D-0516-2016, exactly as published.
Show all FDA fields
- City
- Indiana
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 72699
- Address
- 625 Kolter Dr Ste 4
- Code information
- LOT#:QM114CZF0496, Exp 01/2016; B0025373-050514, B0029738-060914, Exp 02/2016; B0029737-060914, Exp 03/2016.
- Postal code
- 15701-3571
- Report date
- Dec 16, 2015
- Product type
- Drugs
- Recall number
- D-0516-2016
- Classification
- Class II
- Recalling firm
- RemedyRepack Inc.
- Product quantity
- 106 Vials
- Termination date
- Nov 1, 2016
- Reason for recall
- Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Novolin 70/30, 100 Units/mL Solu., Qty: 1 Vial, MFG by: Novo Nordisk, A/S, Bagsvaerd, Denmark DK-2880, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 52125-0414-01
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 11, 2015
- Initial firm notification
- Letter
- Center classification date
- Dec 4, 2015