Recalls / Class II
Class IID-0511-2016
Product
Humulin 70/30, 100 Units/mL Inj, Qty: 10 mL Vial, MFG by: Lilly USA, LLC, Indianapolis, IN 46285, Repackaged by: Remedy Repack, Inc, 625 Kolter Dr, Indiana, PA 15701, NDC 52125-0415-08
- Affected lot / code info
- LOT # B0080702-042715, B0080695-042715, B0097444-082015, Exp 07/2017; B0097443-082015, Exp 02/2018.
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
- 65 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-0511-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.