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D-0741-2016 Class II Terminated

Recalled by Hartley Medical Center Pharmacy, Incorporated — Long Beach, CA

FDA drug recall D-0741-2016 was initiated by Hartley Medical Center Pharmacy, Incorporated on February 4, 2016 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated August 9, 2016). Affected quantity: 1 vial.

Recall Details

Product Type: Drugs
Report Date: March 16, 2016
Initiation Date: February 4, 2016
Termination Date: August 9, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1 vial

Product Description

Morphine Sulfate 9 mg/ml/Sufentanil Cit 180 mcg/ml/Bupivacaine HCL 33 mg/ml, vol. 20 ml vial, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide. No foreign distribution.

Code Information

BUD: 5/3/2016

Other recalls by Hartley Medical Center Pharmacy, Incorporated

D-0744-2016 Class II — Morphine Sulfate 20 mg/ml/Bupivacaine HCL 11.3 mg/ml, vol. 40 ml syringe, Rx onl (February 4, 2016)
D-0746-2016 Class II — Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 30 mg/ml, vol. 20 ml syringe, Rx on (February 4, 2016)
D-0763-2016 Class II — Morphine Sulfate 0.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmac (February 4, 2016)
D-0758-2016 Class II — Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 4 mg/ml, vol. 20 ml syringe, Rx only, (February 4, 2016)
D-0749-2016 Class II — Hydromorphone HCL 20 mg/ml/Bupivacaine HCL 40 mg/ml, vol. 20 ml syringe Rx only, (February 4, 2016)
D-0759-2016 Class II — Morphine Sulfate 11 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy (February 4, 2016)
D-0739-2016 Class II — Morphine Sulfate 0.5 mg/ml/Baclofen 1000 mcg/ml/, vol. 20 ml syringe, Rx only, H (February 4, 2016)
D-0742-2016 Class II — Sufentanil Cit 1000 mcg/ml/Baclofen 300 mcg/ml, vol. 20 ml syringe, Rx only, Har (February 4, 2016)
D-0757-2016 Class II — Hydromorphone HCL 25 mg/ml/Bupivacaine HCL 4 mg/ml, vol. 40 ml syringe, Rx onl (February 4, 2016)
D-0738-2016 Class II — Hydromorphone HCL 10 mg/ml/Baclofen 460 mcg/ml/Bupivacaine HCL, vol. 40 ml syrin (February 4, 2016)