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 4
Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle, a) Quality Choice, Distributed by C.D.M.A. Inc., 43157 W 9 Mile Rd, Novi, MI 48375, NDC# 63868-607-01, UPC 6-35515-98843-9, b) Premier Value, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne, PA 19087 UPC 8-40986-03509-8.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Code information
Lot # SD23032, Exp 04/30/2026
Distribution pattern
MI, PA
drug · product 2 of 4
Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant, Guaifenesin...Expectorant, Alcohol Free, 8 FL OZ (237 mL) bottle, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne PA 19087, UPC 8-40986-03789-4.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Code information
Lot # SD23033, Exp 04/30/2025
Distribution pattern
MI, PA
drug · product 3 of 4
Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant, 1 fl oz (30 mL) bottle, Distributed by C.D.M.A, Inc. 43157 W 9 Mile Rd. Novi, MI 48375, NDC# 63868-676-01, UPC 6-35515-98847-7.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Code information
Lot # SE23034, Exp 05/31/2026
Distribution pattern
MI, PA
drug · product 4 of 4
Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydrochloride 0.05%, Nasal Decongestant, 12 Hours, 1 fl. oz. bottle, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd., Novi, MI 48375, NDC 63868-608-01, UPC 6-35515-98846-0
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
