D-0520-2022 Class II Terminated
FDA drug recall D-0520-2022 was initiated by Teva Pharmaceuticals USA on Jan 10, 2022 and is designated Class II. Reason for recall: Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution. The recall status is terminated (terminated Dec 21, 2022). Affected quantity: 1,175 Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 9, 2022
- Initiation Date
- Jan 10, 2022
- Termination Date
- Dec 21, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,175 Bottles
Product Description
Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0808-02
Reason for Recall
Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
Distribution Pattern
nationwide in the USA
Code Information
Lot #: 100022970, Exp. 08/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0520-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026