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D-0057-2017 Class II Terminated

Recalled by Pharmedium Services, LLC — Lake Forest, IL

FDA drug recall D-0057-2017 was initiated by Pharmedium Services, LLC on Jul 17, 2015 and is designated Class II. Reason for recall: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. The recall status is terminated (terminated Jun 23, 2017). Affected quantity: 54 syringes.

Recall Details

Product Type: Drugs
Report Date: Oct 19, 2016
Initiation Date: Jul 17, 2015
Termination Date: Jun 23, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 54 syringes

Product Description

ketamine HCl Injection, 50 mg per mL (100 mg per 2 mL), 2 mL Total Volume in a syringe, Rx only, PharMEDium, For IV Use, Product code 2R3500.

Reason for Recall

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Distribution Pattern

Nationwide

Code Information

Lot Numbers: 15117045M, 15120050M, 15131014M, Exp between 07/15/15-10/12/15

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0057-2017
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

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

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