FDARecalled May 1, 2024 · #D-0471-2024
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:...
Hazard
Class II — temporary health risk
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Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch. Classification: Class II Distribution: USA nationwide.
Product details
- Product
- 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
- Type
- Drugs
- Manufacturer
- Cipla USA, Inc.
- Model numbers
- IA30390
- UPCs
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