Class II
Terminated
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
This recall has been terminated (originally issued August 25, 2021).
- Recall Initiated
- July 29, 2021
- Posted
- August 25, 2021
- Recall Number
- D-0726-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 20,814 bottles
- Firm Location
- Somerset, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Stability Specification; Out of specification for Osmolarity
Distribution
Nationwide
Lot / Code Info
Lot S001133, exp 7/2022
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