Recalls / Class II
Class IID-0482-2017
Product
Glipizide 2.5 mg ER Tablets, Manufactured by Watson Laboratories, Inc., Parsippany, NJ 07054, Repackaged by RemedyRepack, Indiana, PA 15701, NDC 52125-0764-02
- Affected lot / code info
- Lot # B0129373-021916; Exp. 10/17 00591-0900-30 Original NDC 52125-0764-02 RemedyRepack NDC
Why it was recalled
Failed Dissolution Specifications
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
- 630 pills (21 bottles x 30 pills per HDPE bottle)
- Distribution pattern
- Product was distributed to a sold customer in FL.
Timeline
- Recall initiated
- 2017-02-07
- FDA classified
- 2017-02-18
- Posted by FDA
- 2017-03-01
- Terminated
- 2017-05-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0482-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.