FDA Recalls Ipratropium Bromide Inhalation Solution Due to Manufacturing Deviation
McKesson Medical-Surgical is recalling Ipratropium Bromide Inhalation Solution nationwide due to current good manufacturing practice (cGMP) deviations involving temperature control. The FDA has classified this as a Class II recall.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving manufacturing deviations. However, no illnesses, injuries, or hospitalizations have been reported. The hazard is based on a manufacturing control issue (temperature deviation) rather than confirmed product defect or contamination, warranting a High severity rating.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Ipratropium Bromide Inhalation Solution, 0.02%, 0.5 mg/2.5 mL. This prescription respiratory medication is packaged in 25-count boxes of sterile unit-dose vials and was manufactured by Nephron Pharmaceuticals Corporation.
The recall was initiated because of current good manufacturing practice (cGMP) deviations related to temperature control during manufacturing. McKesson Medical-Surgical was unable to identify which specific lot numbers were received by individual customers; distribution letters included the dates of distribution and the dates when affected product may have been shipped.
Approximately 57 pouches of the recalled product were distributed across the United States. Healthcare providers and patients who have this medication should contact their pharmacy for guidance.
The recalled product
- Product
- IPRATROPIUM BROMIDE (IPRATROPIUM BROMIDE)
- Brand
- IPRATROPIUM BROMIDE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Inhalation solution
- Hazard
- manufacturing-deviation
- temperature-abuse
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (2)
- 0304879801011
- 0304879801004
Distribution
Distributed nationwide across the United States.
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