openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
drug · product 1 of 3
Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0791-19
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information
Lot # B0335344-081717, exp. date 08/2018 Lot # B0363364-110917, exp. date 11/2018 Lot # B0391225-012218, exp. date 01/2019 Lot # B0408458-030618, exp. date 03/2019 Lot # B0384871-010318, exp. date 01/2019 Lot # B0436862-051518, exp. date 05/2019
Distribution pattern
Product was distributed to three customers in FL and VA.
drug · product 2 of 3
Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC: 61786-0792-19
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information
Lot # B0335344-081717, exp. date 08/2018 Lot # B0363364-110917, exp. date 11/2018 Lot # B0391225-012218, exp. date 01/2019 Lot # B0408458-030618, exp. date 03/2019 Lot # B0384871-010318, exp. date 01/2019 Lot # B0436862-051518, exp. date 05/2019
Distribution pattern
Product was distributed to three customers in FL and VA.
drug · product 3 of 3
Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0793-19
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information
Lot # B0362988-110917, exp. date 10/2018 Lot # B0432265-050318, exp. date 05/2019 Lot # B0450321-061218, exp. date 06/2019 Lot # B0450322-061218, exp. date 05/2019 Lot # B0408652-030718, exp. date 02/2019
Distribution pattern
Product was distributed to three customers in FL and VA.
