Recalls / Class II
Class IID-0516-2016
Product
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
- Affected lot / code info
- LOT#:QM114CZF0496, Exp 01/2016; B0025373-050514, B0029738-060914, Exp 02/2016; B0029737-060914, Exp 03/2016.
Why it was recalled
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Recalling firm
- Firm
- RemedyRepack Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 625 Kolter Dr Ste 4, N/A, Indiana, Pennsylvania 15701-3571
Distribution
- Quantity
- 106 Vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-11-11
- FDA classified
- 2015-12-04
- Posted by FDA
- 2015-12-16
- Terminated
- 2016-11-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0516-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.