Multi-event January 2021 FDA Recall Cephalexin by Ascend Laboratories Llc
This Multi-event Class II drug recall was voluntarily initiated by Ascend Laboratories Llc on January 22, 2021 for the product Cephalexin. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0264-2021
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
01-22-2021
02-24-2021
23,436 200 mL bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Ascend Laboratories LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
12-02-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# : 19141869, 19141870, EXP 3/2021; 19142762, EXP 5/2021; 19143826, 19143923,19143941, 19143954 EXP 7/2021
Affected Packages Involved in this Recall
Recall Number: D-0263-2021
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
01-22-2021
02-24-2021
14,205 100 mL bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Ascend Laboratories LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
12-02-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-88
Batch or Lot Expiration Information
Lot# 19144841, Exp 9/2021; 20141673 Exp 4/2022.
