D-1107-2018 Class II Terminated
FDA drug recall D-1107-2018 was initiated by Preferred Pharmaceuticals, Inc on Aug 15, 2018 and is designated Class II. Reason for recall: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. The recall status is terminated (terminated Jan 18, 2019). Affected quantity: 9 bottles consisting of 90 tables each bottle.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 29, 2018
- Initiation Date
- Aug 15, 2018
- Termination Date
- Jan 18, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 bottles consisting of 90 tables each bottle
Product Description
Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx Only, Preferred Pharmaceuticals, Inc., 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807, NDC 68788-6882-9
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Distribution Pattern
Products were distributed to one distributor in Alabama who may have further distributed the product to the consumer level.
Code Information
Lot # G2017F NDC 68788-6882-9
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1107-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026