Cipla USA Inc. recalls 20,352 packs of Albuterol Sulfate Inhalation Aerosol after failing stability specifications. The defective lots were distributed nationwide in the United States. The issue involves out of specification results in particle size distribution at the 12-month time point. Patients and healthcare providers should stop use and contact Cipla USA for guidance.
Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
Consumers and healthcare providers should stop using this product immediately. Contact Cipla USA, Inc. or your healthcare provider for guidance. Notification method: Letter
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Albuterol sulfate inhalation aerosol is a bronchodilator used to treat or prevent bronchospasm in people with reversible obstructive airway disease.
The identified issue is a stability failure affecting particle size distribution, which could impact drug delivery.
This recall is not part of a broader industry pattern.
No injuries reported in the provided data. Consumers should await further instructions from Cipla USA or their healthcare providers.
Product label and packaging display NDC, lot number, and Exp. date.
Recall activation started 2025-07-24. Replacement or refund process will be communicated by Cipla USA via mailed letter (no explicit timeline).
Keep packaging, lot number, NDC, and recall notice; record dates of contact and responses
Model numbers: Lot 4IB0519. Expiration: 04/30/2026. NDC 69097-142-60. Quantity: 20,352 packs (1x 200 MD). Sold nationwide in the United States. Manufactured by Cipla Ltd, Indore SEZ, Pithampur, India for Cipla USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059.
No injuries or incidents are reported in the provided data.
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