Novel Laboratories, Inc. d.b.a LUPIN: Drug Recall
Recall #D-0726-2021 · 07/29/2021
Class II: Risk
Recall Details
- Recall Number
- D-0726-2021
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Novel Laboratories, Inc. d.b.a LUPIN
- Status
- Terminated
- Date Initiated
- 07/29/2021
- Location
- Somerset, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20,814 bottles
Reason for Recall
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
Distribution Pattern
Nationwide
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.