D-0001-2019 Class II Terminated
FDA drug recall D-0001-2019 was initiated by Teva Pharmaceuticals USA on Sep 21, 2018 and is designated Class II. Reason for recall: Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing. The recall status is terminated (terminated May 1, 2019). Affected quantity: 313 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 10, 2018
- Initiation Date
- Sep 21, 2018
- Termination Date
- May 1, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 313 bottles
Product Description
Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5416-01 Yellow, round, flat-faced, beveled-edge, unscored tablet. Debossed with 13 on one side and plain on the other side.
Reason for Recall
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
Distribution Pattern
Distributed nationwide in the USA
Code Information
Lot #: 34034024B, Exp 02/20
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0001-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026