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D-1281-2016 Class II Terminated

Recalled by Pharmakon Pharmaceuticals, Inc. — Noblesville, IN

FDA drug recall D-1281-2016 was initiated by Pharmakon Pharmaceuticals, Inc. on Apr 20, 2016 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated Jan 11, 2018). Affected quantity: 25.

Recall Details

Product Type: Drugs
Report Date: Jul 20, 2016
Initiation Date: Apr 20, 2016
Termination Date: Jan 11, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 25

Product Description

Morphine Sulfate (PF) 0.5mg/mL in 0.9% Sodium Chloride 1mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0322-78

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

Code Information

All Sterile Compounded Products within Expiry

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1281-2016
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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