PlainRecalls
FDA Drug Moderate Class II Terminated

ALBUTEROL SULFATE IN 90MCG per actuation, 200 Metered Inhalations, Rx Only, 8.5 g Net Contents, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India. NDC: 68180-963-01

Reported: January 3, 2024 Initiated: January 26, 2022 #D-0163-2024

Product Description

ALBUTEROL SULFATE IN 90MCG per actuation, 200 Metered Inhalations, Rx Only, 8.5 g Net Contents, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India. NDC: 68180-963-01

Reason for Recall

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Details

Recalling Firm
CARDINAL HEALTHCARE
Units Affected
11 cartons
Distribution
Nationwide USA
Location
Dublin, OH

Frequently Asked Questions

What product was recalled?
ALBUTEROL SULFATE IN 90MCG per actuation, 200 Metered Inhalations, Rx Only, 8.5 g Net Contents, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India. NDC: 68180-963-01. Recalled by CARDINAL HEALTHCARE. Units affected: 11 cartons.
Why was this product recalled?
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 3, 2024. Severity: Moderate. Recall number: D-0163-2024.