Recalls / Class II
Class IID-0875-2022
Product
GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19
- Brand name
- Gavilyte - C
- Generic name
- Polyethylene Glycol-3350 And Electrolytes With Flavor Pack
- Active ingredients
- Polyethylene Glycol 3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride, Sodium Sulfate Anhydrous
- Route
- Oral
- NDC
- 43386-060
- FDA application
- ANDA090186
- Affected lot / code info
- Lot # S001132, exp. date July 2022 NDC # 43386-060-19
Why it was recalled
Failed Stability Specification
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals,Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 26,910 bottles
- Distribution pattern
- Product was distributed nationwide, including Puerto Rico.
Timeline
- Recall initiated
- 2022-04-27
- FDA classified
- 2022-05-16
- Posted by FDA
- 2022-05-25
- Terminated
- 2023-04-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0875-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.