July 2019 FDA Recall Drug by Ascend Laboratories Llc
D-1515-2019 - Failed Dissolution Specifications

This Class II drug recall was voluntarily initiated by Ascend Laboratories Llc on July 19, 2019 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed in Product was shipped to wholesalers throughout the United States. and the recall is currently terminated.

Recall Number: D-1515-2019

Reason for Recall
Failed Dissolution Specifications
Initiated
07-19-2019
Reported
07-31-2019
Quantity
a) 5,472 bottles and b) 5,880 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83378
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was shipped to wholesalers throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-07-2021
Product Description About Product Description
Full technical description of the product.
Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05) bottles, Rx only, Manufactured by: Alkem Laboratories, Ltd, Mumbai INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ

Batch or Lot Expiration Information

Lot# a)
Lot# 19140443, exp. date 12/2020
Lot# 19140525, 19140535, exp. date 01/2021 and b)
Lot# 19140756, exp. date 12/2020
Lot# 19140757
Lot# 19140758, exp. date 01/2021
Lot# 19141696
Lot# 19141793, exp. date 03/2021