Drug Enforcement D-0471-2024

Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.

Status

Terminated

Classification

Class II

Report Date

May 1, 2024

Termination Date

July 9, 2025

Product Information

Product description
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials ( 6 pouches of 5 - 3 mL vials), Rx only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-173-53
Product quantity
59244/3ml FFS packs
Reason for recall
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
USA nationwide.

Location & Firm

Recalling firm
Cipla USA, Inc.
Address
10 Independence Blvd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0471-2024
Event ID
94289
Recall initiation date
March 26, 2024
Center classification date
April 24, 2024
Code info
Lot # IA30390, Exp 4/30/2025, IA30517, Exp 6/30/ 2025
More code info
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