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Pharmedium Services, LLC

FDA Regulatory Profile

Pharmedium Services, LLC has 291 FDA recalls (19 Class I), 19 inspections, 0 510(k) clearances and 3 compliance actions on record.

Latest recall
D-1086-2020 · Class II · Mar 16, 2020
Latest inspection
Apr 11, 2018 · OAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls291 (19 Class I)Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections19Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions3Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

NumberClassProductDate
D-1086-2020Class IIsuccinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium…Mar 16, 2020
D-1088-2020Class IIePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringe, For IV use…Mar 16, 2020
D-1089-2020Class IIfentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30…Mar 16, 2020
D-1092-2020Class IIfentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, For IV Use, Rx Only…Mar 16, 2020
D-1093-2020Class IIfentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use, Rx Only…Mar 16, 2020
D-1081-2020Class IIePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use…Mar 16, 2020
D-1090-2020Class IIePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD Syringe, For IV Use…Mar 16, 2020
D-1087-2020Class IIrocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use, PharMEDium 13N. Davis…Mar 16, 2020
D-1085-2020Class IIfentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride…Mar 16, 2020
D-1091-2020Class IIePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe, For IV…Mar 16, 2020
D-1082-2020Class IInICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 10 ml in a 20mL…Mar 16, 2020
D-1084-2020Class IIHYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 mL, 30 mL in a 35…Mar 16, 2020
D-1083-2020Class IIrocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N…Mar 16, 2020
D-0627-2020Class IIINORepinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP (16 mcg per mL) Total…Dec 16, 2019
D-0626-2020Class IIINORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 mcg per mL) Total…Dec 16, 2019
D-0625-2020Class IIINORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 mcg per mL) Total…Dec 16, 2019
D-1488-2019Class IHydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringe, PharMEDium 913 N…Jun 7, 2019
D-0374-2019Class II0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD Syringe, 10…Jan 2, 2019
D-0334-2019Class IIFentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% in Sodium Chloride 0.9%…Dec 5, 2018
D-0333-2019Class IIFentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%…Dec 5, 2018

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 11, 2018Lake Forest, ILDrugsOfficial Action Indicated (OAI)3005051736
Jan 5, 2018Cleveland, MSDrugsOfficial Action Indicated (OAI)3004153061
Dec 22, 2017Sugar Land, TXDrugsOfficial Action Indicated (OAI)3000717703
Dec 15, 2017Memphis, TNDrugsOfficial Action Indicated (OAI)3007045542
Dec 13, 2017Dayton, NJDrugsOfficial Action Indicated (OAI)2242985
May 26, 2016Dayton, NJDrugsOfficial Action Indicated (OAI)2242985
Jan 21, 2016Memphis, TNDrugsOfficial Action Indicated (OAI)3007045542
Jan 4, 2016Lake Forest, ILDrugsOfficial Action Indicated (OAI)3005051736
Sep 24, 2015Sugar Land, TXDrugsOfficial Action Indicated (OAI)3000717703
Jul 13, 2015Dayton, NJDrugsOfficial Action Indicated (OAI)2242985
Jul 10, 2015Memphis, TNDrugsOfficial Action Indicated (OAI)3007045542
Mar 22, 2013Memphis, TNDrugsOfficial Action Indicated (OAI)3007045542
Feb 28, 2013Dayton, NJDrugsOfficial Action Indicated (OAI)2242985
Feb 27, 2013Sugar Land, TXDrugsOfficial Action Indicated (OAI)3000717703
Feb 22, 2013Cleveland, MSDrugsOfficial Action Indicated (OAI)3004153061
Dec 9, 2010Sugar Land, TXDrugsVoluntary Action Indicated (VAI)3000717703
Sep 30, 2009Memphis, TNDrugsOfficial Action Indicated (OAI)3007045542
Aug 17, 2009Cleveland, MSDrugsOfficial Action Indicated (OAI)3004153061
Apr 21, 2009Cleveland, MSDrugsOfficial Action Indicated (OAI)3004153061

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3005051736Lake Forest, IL2Apr 11, 2018
FEI 3004153061Cleveland, MS4Jan 5, 2018
FEI 3000717703Sugar Land, TX4Dec 22, 2017
FEI 3007045542Memphis, TN5Dec 15, 2017
FEI 2242985Dayton, NJ4Dec 13, 2017

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.