Recalls / Class II
Class IID-0726-2021
Product
GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, USA Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 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 S001133, exp 7/2022
Why it was recalled
Failed Stability Specification; Out of specification for Osmolarity
Recalling firm
- Firm
- Novel Laboratories, Inc. d.b.a LUPIN
- Manufacturer
- Lupin Pharmaceuticals,Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Campus Dr, N/A, Somerset, New Jersey 08873-1145
Distribution
- Quantity
- 20,814 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2021-07-29
- FDA classified
- 2021-08-13
- Posted by FDA
- 2021-08-25
- Terminated
- 2022-11-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0726-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.