D-0056-2017 Class II Terminated

Recalled by Pharmedium Services, LLC — Lake Forest, IL

FDA drug recall D-0056-2017 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: 12,173 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
12,173 syringes

Product Description

ketamine HCl Injection, 50 mg per mL, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3348.

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: 15117083M, 15117090M, 15118047M, 15121052M, 15124079M, 15126020M, 15127007M, 15127096M, 15133014M, 15133068M, 15134067M, 15139089M, 15140069M, 15141027M, 15141043M, 15142095M, 15146008M, 15149111M, 15149116M, 151730004M, 151730116M, 151880152M, 151890126M, 151930170M, 151940024M, 151940182M, 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-0056-2017
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.