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
Reported: May 1, 2024 Initiated: March 26, 2024 #D-0471-2024
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
Reason for Recall
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Details
- Recalling Firm
- Cipla USA, Inc.
- Units Affected
- 59244/3ml FFS packs
- Distribution
- USA nationwide.
- Location
- Warren, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Cipla USA, Inc.. Units affected: 59244/3ml FFS packs.
Why was this product recalled? ▼
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 1, 2024. Severity: Moderate. Recall number: D-0471-2024.
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