Recalls / Class II
Class IID-0491-2017
Product
glipiZIDE Extended-Release Tablets, 5 mg, 1000 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-0342-10
- Affected lot / code info
- Batch # 3074621, June 2018
Why it was recalled
Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, N/A, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 1338 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-01-19
- FDA classified
- 2017-02-24
- Posted by FDA
- 2017-03-08
- Terminated
- 2017-07-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0491-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.