Hartley Medical Center Pharmacy, Incorporated

FDA Regulatory Profile

Hartley Medical Center Pharmacy, Incorporated appears in FDA public data with 32 recalls — including 2 Class I (most serious) —, 0 510(k) clearances, 1 FDA inspection, and 1 compliance action on record. Its most recent recall (D-0750-2016, Class II) was initiated on February 4, 2016.

Summary

Total Recalls
32 (2 Class I)
510(k) Clearances
0
Inspections
1
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0750-2016Class IIHydromorphone HCL 25 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CAFebruary 4, 2016
D-0744-2016Class IIMorphine Sulfate 20 mg/ml/Bupivacaine HCL 11.3 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr PFebruary 4, 2016
D-0746-2016Class IIHydromorphone HCL 10 mg/ml/Bupivacaine HCL 30 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr February 4, 2016
D-0763-2016Class IIMorphine Sulfate 0.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CAFebruary 4, 2016
D-0758-2016Class IIHydromorphone HCL 10 mg/ml/Bupivacaine HCL 4 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr PhaFebruary 4, 2016
D-0749-2016Class IIHydromorphone HCL 20 mg/ml/Bupivacaine HCL 40 mg/ml, vol. 20 ml syringe Rx only, Hartley Med Ctr PhaFebruary 4, 2016
D-0759-2016Class IIMorphine Sulfate 11 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CAFebruary 4, 2016
D-0739-2016Class IIMorphine Sulfate 0.5 mg/ml/Baclofen 1000 mcg/ml/, vol. 20 ml syringe, Rx only, Hartley Med Ctr PharmFebruary 4, 2016
D-0742-2016Class IISufentanil Cit 1000 mcg/ml/Baclofen 300 mcg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr PharmacFebruary 4, 2016
D-0757-2016Class IIHydromorphone HCL 25 mg/ml/Bupivacaine HCL 4 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr PFebruary 4, 2016
D-0765-2016Class IISufentanil Cit 50 mcg/ml/Clonidine HCL 1 mcg/ml/Bupivacaine HCL 5 mg/ml, vol. 20 ml syringe, Rx onlyFebruary 4, 2016
D-0754-2016Class IIMorphine Sulfate 1.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CAFebruary 4, 2016
D-0738-2016Class IIHydromorphone HCL 10 mg/ml/Baclofen 460 mcg/ml/Bupivacaine HCL, vol. 40 ml syringe, Rx only, HartleyFebruary 4, 2016
D-0743-2016Class IIMorphine Sulfate 0.6 mg/ml, vol. 200 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CAFebruary 4, 2016
D-0740-2016Class IIHydromorphone 12 mg/ml/Baclofen 450 mcg/ml, vol. 20 ml, syringe, Rx only, Hartley Med Ctr Pharmacy, February 4, 2016
D-0741-2016Class IIMorphine Sulfate 9 mg/ml/Sufentanil Cit 180 mcg/ml/Bupivacaine HCL 33 mg/ml, vol. 20 ml vial, Rx onlFebruary 4, 2016
D-0755-2016Class IIFentanyl Citrate 1.275 mg/ml/Baclofen 150 mcg/ml/Bupivacaine HCL 20 mg/ml/ Clonidine HCL 450 mcg/mlFebruary 4, 2016
D-0736-2016Class IIMorphine Sulfate 6 mg/ml/Bupivacaine HCL 32 mg/ml, vol. 22 ml syringe, Rx only, Hartley Med Ctr PharFebruary 4, 2016
D-0756-2016Class IIHydromorphone HCL 1 mg/ml, vol. 22 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CAFebruary 4, 2016
D-0764-2016Class IIHydromorphone HCL 0.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CAFebruary 4, 2016