D-0304-2019 Class II Ongoing
FDA drug recall D-0304-2019 was initiated by Teva Pharmaceuticals USA on Nov 27, 2018 and is designated Class II. Reason for recall: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. The recall status is ongoing. Affected quantity: 39,617 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 19, 2018
- Initiation Date
- Nov 27, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 39,617 bottles
Product Description
Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) 30-count bottles (NDC 0093-7961-56) & 90-count bottles (NDC 0093-7691-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
Reason for Recall
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Distribution Pattern
USA Nationwide including Puerto Rico.
Code Information
NDC 0093-7691-56 & NDC 0093-7691-98 Lot # 24X012, 24X013
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0304-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026