D-1341-2020 Class II Terminated
FDA drug recall D-1341-2020 was initiated by Alembic Pharmaceuticals Limited on Jun 10, 2020 and is designated Class II. Reason for recall: Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count. The recall status is terminated (terminated Jan 19, 2022). Affected quantity: 19,153 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 1, 2020
- Initiation Date
- Jun 10, 2020
- Termination Date
- Jan 19, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19,153 bottles
Product Description
Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA, NDC 62332-097-30.
Reason for Recall
Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.
Distribution Pattern
Nationwide in the U.S.
Code Information
Lot: 1905003298 Exp. 01/31/2021
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1341-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026