D-0097-2017 Class II Terminated
FDA drug recall D-0097-2017 was initiated by Hospira Inc., A Pfizer Company on Sep 16, 2016 and is designated Class II. Reason for recall: Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled… The recall status is terminated (terminated Jul 31, 2019). Affected quantity: 4768 vials.
Recall details
- Product Type
- Drugs
- Report Date
- Oct 19, 2016
- Initiation Date
- Sep 16, 2016
- Termination Date
- Jul 31, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4768 vials
Product description
Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1610-50.
Reason for recall
Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
Distribution pattern
Nationwide and Puerto Rico
Code information
Lot #: 59310DD, Exp 1NOV2017
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0097-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026