D-0089-2017 Class II Terminated
FDA drug recall D-0089-2017 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: 6970 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
- 6970 syringes
Product Description
rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3321.
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: 151120168M, 151120169M, 15112027M, 15112096M, 15113021M, 15113080M, 15113081M, 15113082M, 15113083M, 15113084M, 15113085M, 15113086M, 15113087M, 15113088M, 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-0089-2017
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026