D-0830-2022 Class II Terminated
FDA drug recall D-0830-2022 was initiated by SCA Pharmaceuticals on Apr 25, 2022 and is designated Class II. Reason for recall: CGMP Deviations The recall status is terminated (terminated Sep 9, 2022). Affected quantity: 424 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- May 11, 2022
- Initiation Date
- Apr 25, 2022
- Termination Date
- Sep 9, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 424 bags
Product Description
Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0231-32
Reason for Recall
CGMP Deviations
Distribution Pattern
Product was distributed nationwide within the United States
Code Information
Lot #: 1222035837, Exp. Date 22-Jul-22 Lot #: 1222035804, Exp. Date 25-Jul-22
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0830-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026