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
15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag, Rx only, PharMEDium Serivces, LLC
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
Code information
Lot #: 180040003D, Exp 3/18/18
Distribution pattern
Product was distributed to SC, FL, NY, NY,WA
drug · product 2 of 3
0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette, Rx only, PharMEDium Serivces, LLC
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
Code information
Lot #: 180030029D, Exp 2/18/18
Distribution pattern
Product was distributed to SC, FL, NY, NY,WA
drug · product 3 of 3
100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe, Rx only, PharMEDium Serivces, LLC
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
