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 6
morphine sulfate 1 mg per mL in 0.9% Sodium Chloride, (Total morphine Dose 100 mg/100 mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, (877) 550-5059; labeled as a) NDC: 70004-0100-59; b) NDC: 70004-100-58.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Code information
Lots: a) 20170707@34, BUD:10/5/2017; 20170710@21, BUD: 10/8/2017; b) 20170706@44, BUD: 10/4/2017
Distribution pattern
Nationwide in the USA
drug · product 2 of 6
fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride, (Total fentaNYL Dose 1,000 mcg/100 mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0202-32.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Code information
Lot: 20170707@27, BUD: 10/5/2017
Distribution pattern
Nationwide in the USA
drug · product 3 of 6
ceFAZolin 3 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 115 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0524-32.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Code information
Lot: 20170707@26, BUD: 8/21/2017
Distribution pattern
Nationwide in the USA
drug · product 4 of 6
Diltiazem 125 mg in 0.9% Sodium Chloride, 1 mg per mL, Total Volume 125 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0541-35.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Code information
Lot: 20170707@54, BUD: 10/4/2017
Distribution pattern
Nationwide in the USA
drug · product 5 of 6
MAGNESIUM Sulfate 4 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0737-32.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Code information
Lot: 20170710@54, BUD: 10/8/2017
Distribution pattern
Nationwide in the USA
drug · product 6 of 6
PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride, (Final Concentration = 0.1 mg per mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0810-32.
