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
Reported: February 24, 2021 Initiated: January 22, 2021 #D-0264-2021
Product Description
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
Reason for Recall
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Details
- Recalling Firm
- Ascend Laboratories LLC
- Units Affected
- 23,436 200 mL bottles
- Distribution
- Nationwide in the USA
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Ascend Laboratories LLC. Units affected: 23,436 200 mL bottles.
Why was this product recalled? ▼
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 24, 2021. Severity: Moderate. Recall number: D-0264-2021.
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