Class III
Terminated
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC a) 36000-002-10 and b) 36000-002-06.
- Company
- Renaissance Lakewood, Llc
- Recall Initiated
- July 11, 2018
- Posted
- August 8, 2018
- Recall Number
- D-1033-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 12088 bags
- Firm Location
- Lakewood, NJ, United States
Reason for Recall
Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot #: a) A060966, A060967, A060965, A061023, Exp 07/18; b) A060962, Exp 02/19
More recalls by Renaissance Lakewood, Llc
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), package...
Apr 25, 2018 · Class II
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