Premier Pharmacy Labs Inc

FDA Regulatory Profile

Premier Pharmacy Labs Inc has 24 FDA recalls, 3 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest recall
D-1416-2019 · Class II · Jun 18, 2019
Latest inspection
Jun 12, 2019 · OAI

Reviewing Premier Pharmacy Labs Inc as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Premier Pharmacy Labs Inc yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls24Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections3Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

NumberClassProductDate
D-1416-2019Class IIIsoproterenol HCL in D5W (Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL Sterile Single-Dose Bag…Jun 18, 2019
D-1417-2019Class IIIsoproterenol HCL in D5W (Non Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL Sterile Single-Dose…Jun 18, 2019
D-1427-2019Class IISUCCINYLcholine Chloride, 100mg/5mL (20mg/mL), 5mL Sterile Single-Use Syringe, Rx only, Premier…Jun 18, 2019
D-1419-2019Class IILidocaine 0.5%/Phenylephrine 0.75% P.F. INJ, 1mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265…Jun 18, 2019
D-1423-2019Class IIOrphenadrine Citrate Sterile Injectable Solution *Contains Sulfites*, 30mg/mL, 1mL Sterile…Jun 18, 2019
D-1422-2019Class IINeostigmine Methylsulfate, 5mg/5mL (1mg/mL), 5mL Single Dose Syringe, Rx only, Premier Pharmacy…Jun 18, 2019
D-1418-2019Class IIIsoproterenol HCL in D5W, 500mcg/50mL (10mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier…Jun 18, 2019
D-1426-2019Class IISodium Bicarbonate INJ 8.4%, 50 mEq/50mL (84mg/mL) (1mEq/mL), 50mL Sterile SDV, Rx only, Premier…Jun 18, 2019
D-1413-2019Class IIChlorproMAZINE HCL INJ, 25mg/mL, *Contains Sulfites*, 1mL in a 5mL Sterile SDV, Rx only, Premier…Jun 18, 2019
D-1414-2019Class IIDexamethasone Sodium Phosphate Preservative Free Sterile Solution for INJ, 24mg/mL, 1mL Sterile…Jun 18, 2019
D-1425-2019Class IIRiboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg/3mL (6.35 mg/mL), 3 mL Dropper Bottle, Rx…Jun 18, 2019
D-1420-2019Class IIMitomycin Preservative Free Irrigation, 40mg/10mL (4mg/mL), 10mL SDV, Rx only, Premier Pharmacy…Jun 18, 2019
D-1428-2019Class IISUCCINYLcholine Chloride, 200mg/10mL (20mg/mL), 10mL Sterile Single Dose Syringe, Rx only, Premier…Jun 18, 2019
D-1411-2019Class IIAtropine Sulfate PF INJ, 0.8 mg/2 mL (0.4 mg/mL), 2mL Single Dose Syringe, Rx only, Premier Pharmacy…Jun 18, 2019
D-1421-2019Class IINaloxone HCL Preserved INJ, 500mg/50mL (10mg/mL), 50mL Sterile MDV, Rx only, Premier Pharmacy Labs…Jun 18, 2019
D-1412-2019Class IIBrilliant Blue Ophthalmic PF INJ, 0.5mg/mL (0.05%), 1 mL SDV, Rx only, Premier Pharmacy Labs, 8265…Jun 18, 2019
D-1415-2019Class IIDroperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Single-Use Syringe, Rx…Jun 18, 2019
D-1424-2019Class IIPhenylephrine HCL PF INJ in 0.9% Sodium Chloride, 1000mcg/10mL (100mgc/mL), *Contains Sulfites*…Jun 18, 2019
D-0702-2018Class IINEOstigmine Methylsulfate (1 mg/mL) 3mg per 3mL. 3mL Single Dose Syringe. Premier Pharmacy Labs…Apr 11, 2018
D-0699-2018Class IIMorphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical…Apr 11, 2018

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 12, 2019Weeki Wachee, FLDrugsOfficial Action Indicated (OAI)3007271263
Jun 13, 2016Weeki Wachee, FLDrugsOfficial Action Indicated (OAI)3007271263
May 9, 2014Weeki Wachee, FLDrugsOfficial Action Indicated (OAI)3007271263

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 3007271263Weeki Wachee, FL3Jun 12, 2019

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