D-0491-2017 Class II Terminated
FDA drug recall D-0491-2017 was initiated by Mylan Pharmaceuticals Inc. on Jan 19, 2017 and is designated Class II. Reason for recall: Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets The recall status is terminated (terminated Jul 20, 2017). Affected quantity: 1338 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Mar 8, 2017
- Initiation Date
- Jan 19, 2017
- Termination Date
- Jul 20, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1338 bottles
Product description
glipiZIDE Extended-Release Tablets, 5 mg, 1000 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-0342-10
Reason for recall
Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets
Distribution pattern
Nationwide
Code information
Batch # 3074621, June 2018
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0491-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026