Why it was recalled
Failed Stability Specification; Out of specification for Osmolarity
Product description
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
Lot numbers, UPCs & expiration codes
Lot S001133, exp 7/2022
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0726-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 29, 2021
- FDA report date
- Aug 25, 2021
- Quantity
- 20,814 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novel Laboratories, Inc. d.b.a LUPIN
Original FDA data
Every field from FDA enforcement report D-0726-2021, exactly as published.
Show all FDA fields
- City
- Somerset
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88390
- Address
- 400 Campus Dr
- Code information
- Lot S001133, exp 7/2022
- Postal code
- 08873-1145
- Report date
- Aug 25, 2021
- Product type
- Drugs
- Recall number
- D-0726-2021
- Classification
- Class II
- Recalling firm
- Novel Laboratories, Inc. d.b.a LUPIN
- Product quantity
- 20,814 bottles
- Termination date
- Nov 14, 2022
- Reason for recall
- Failed Stability Specification; Out of specification for Osmolarity
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 29, 2021
- Initial firm notification
- Letter
- Center classification date
- Aug 13, 2021