Respiratory inhalation medication recalled for temperature storage deviation
Cardinal Healthcare is recalling an ipratropium bromide and albuterol sulfate inhalation solution nationwide after the product was exposed to temperatures outside labeled storage conditions. The deviation may affect drug potency.
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: FDA Class II manufacturing deviation affecting a respiratory medication's potency due to temperature exposure. Although no reported illnesses or injuries, this creates risk-of-harm for patients who depend on medication efficacy, meeting the High severity criterion for risk-of-harm products without reported injury.
Plain-English summary
Cardinal Healthcare is recalling Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg per 3 mL), a respiratory medication used to treat bronchospasm, across the United States. Batch 21C56 of this product was exposed to temperatures outside the manufacturer's labeled storage conditions during manufacturing.
The temperature deviation is a Current Good Manufacturing Practice (CGMP) violation that may affect the potency and efficacy of the medication. Patients may not receive the intended therapeutic benefit from using affected units.
The recalled product consists of 2 cartons containing 60 sterile unit-dose vials (two pouches of 30 vials each), manufactured by The Ritedose Corporation in Columbia, South Carolina and distributed by Cipla USA Inc. in Warren, New Jersey. The product's National Drug Code (NDC) is 69097-840-64.
Patients who have received this medication should consult their healthcare provider if they have concerns. Healthcare providers should remove affected product from circulation and replace it with properly stored product.
The recalled product
- Product
- IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE (IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE)
- Brand
- IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug — Inhalation Solution
- Hazard
- temperature-exposure
- potency-loss
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 (1)
- Batch 21C56
Distribution
Distributed nationwide across the United States.
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