D-0875-2022 Class II Terminated
FDA drug recall D-0875-2022 was initiated by Lupin Pharmaceuticals Inc. on Apr 27, 2022 and is designated Class II. Reason for recall: Failed Stability Specification The recall status is terminated (terminated Apr 13, 2023). Affected quantity: 26,910 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 25, 2022
- Initiation Date
- Apr 27, 2022
- Termination Date
- Apr 13, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26,910 bottles
Product Description
GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19
Reason for Recall
Failed Stability Specification
Distribution Pattern
Product was distributed nationwide, including Puerto Rico.
Code Information
Lot # S001132, exp. date July 2022 NDC # 43386-060-19
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0875-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026