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.
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: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
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: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
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: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Code information
Lot: 16876, Exp.: 05/31/2023
Distribution pattern
Nationwide in the United States including Guam and the Northern Mariana Islands.
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: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Code information
Lot: 15644, Exp.: 05/31/2022
Distribution pattern
Nationwide in the United States including Guam and the Northern Mariana Islands.
drug · product 5 of 5
Erythromycin Topical Gel USP, 2%, Net Wt 60 g tube, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-053-68
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: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Code information
Lot: 15723, Exp.: 06/30/2022
Distribution pattern
Nationwide in the United States including Guam and the Northern Mariana Islands.