D-0125-2017 Class II Terminated
FDA drug recall D-0125-2017 was initiated by Pharmedium Services, LLC on Oct 12, 2016 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation. The recall status is terminated (terminated Nov 8, 2016). Affected quantity: 1550 units.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 9, 2016
- Initiation Date
- Oct 12, 2016
- Termination Date
- Nov 8, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1550 units
Product Description
Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only, PharMEDium Services, LLC, Memphis, TN, NDC 61553-0364-65.
Reason for Recall
Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation.
Distribution Pattern
Nationwide
Code Information
Lot #: 162790012M, Exp. 1/3/2017
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0125-2017
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026