Class II
Terminated
Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-68
- Company
- Ascend Laboratories, Llc
- Recall Initiated
- January 22, 2021
- Posted
- February 24, 2021
- Recall Number
- D-0264-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 23,436 200 mL bottles
- Firm Location
- Parsippany, NJ, United States
Reason for Recall
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Distribution
Nationwide in the USA
Lot / Code Info
Lot #: 19141869, 19141870, EXP 3/2021; 19142762, EXP 5/2021; 19143826, 19143923,19143941, 19143954 EXP 7/2021
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