Nephron Recalls Ipratropium Bromide and Albuterol Sulfate Inhalation Solution
Nephron Pharmaceuticals is recalling Ipratropium Bromide and Albuterol Sulfate inhalation solution due to a lack of assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of non-sterile contamination in an inhalation product.
Plain-English summary
Nephron Pharmaceuticals Corp. is recalling Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution. The affected product is packaged in 30x3 mL sterile unit-dose vials, available in 30-count and 60-count cartons. The recall covers Lot D4E20A and Lot D4C21A, both with an expiration date of 3/2016.
The recall was initiated due to a lack of assurance of sterility and the potential exposure to non-sterile lubricant during the filling process. The product was distributed nationwide. The total quantity recalled is 85,248 cartons of the 30-count package and 35,292 cartons of the 60-count package.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for a replacement or refund. This is a prescription-only medication used for respiratory conditions.
The recalled product
- Product
- IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE (IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE)
- Brand
- IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE
- Manufacturer
- Nephron Pharmaceuticals Corp.
- Category
- Drug — Inhalation Solution
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- a) Lot D4E20A
- exp 3/2016 and b) Lot D4C21A
- exp 3/2016
UPCs (1)
- 0304870201018
Distribution
Distributed nationwide across the United States.
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