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 13
ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use Preservative Free PharMEDium 913 N. Davis Ave. Cleveland, MS NDC 71030-003-12
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Code information
193540006D, Exp 3/22/2020
Distribution pattern
Distributed Nationwide in the US
drug · product 3 of 13
rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave. Cleveland, MS. Preservative Free, NDC 71019-321-10
HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 mL, 30 mL in a 35 mL Monoject Barrel Syringe, PharMEDium Services LLC 913 M. Davis Ave Cleveland, MS. NDC 61553-166-44
fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%. Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 36732 NDC 61553-113-50
ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringe, For IV use, Preservative Free, PharMEDium 913 W Davis Ave Cleveland MS 38732 NDC 71030-003-09
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Code information
193500012D, Exp 3/16/2020
Distribution pattern
Distributed Nationwide in the US
drug · product 9 of 13
fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL Monoject Barrel Syringe, PharMEDium Services, LLC 913 N. Davis Avenue Cleveland, MS 38732. NDC 61553-672-44
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Code information
193510008D 3/17/2020 193580004D 3/25/020
Distribution pattern
Distributed Nationwide in the US
drug · product 10 of 13
ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD Syringe, For IV Use, Rx Only, PharMEDium 913 N. Davis Ave. Cleveland, MS 98732 NDC 71030-003-02
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Code information
193510031D, Exp 3/17/2020
Distribution pattern
Distributed Nationwide in the US
drug · product 11 of 13
ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe, For IV Use, Rx Only, PharMEDium 913 N Davis Avenue Cleveland, MS NDC 71030-001-09
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Code information
193520006D 3/18/2020 193530009D 3/19/2020
Distribution pattern
Distributed Nationwide in the US
drug · product 12 of 13
fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, For IV Use, Rx Only, PharMEDium Services, LLC 36 Stutte Road Dayton, NJ. NDC 61553-306-33
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Code information
193530007D, Exp 3/19/2020
Distribution pattern
Distributed Nationwide in the US
drug · product 13 of 13
fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use, Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 05810. NDC 61553-303-28
