Prescription inhalation drug recalled due to sterility assurance failure
Cipla recalls Arformoterol Tartrate Inhalation Solution due to environmental monitoring failure affecting sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 recall due to lack of sterility assurance from environmental monitoring failure. While no illnesses or injuries have been reported, a sterile inhalation drug with potential contamination poses direct risk of harm. This qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Cipla Ltd. is recalling Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL sterile unit-dose vials, due to a failure in environmental monitoring that compromised assurance of sterility. This is a Class II recall affecting 9,041 cartons distributed nationwide to pharmaceutical distributors and wholesalers.
The affected batch numbers are IA10082, IA10083, IA10084, IA10085, IA10086 (expiring 01/2023) and IA10122 through IA10130 (expiring 02/2023). The product was manufactured by Cipla Ltd., Indore SEZ, Pithampur, India, and distributed by Cipla USA, Inc., Warren, New Jersey.
Patients and healthcare providers who have received affected batches should contact their pharmacist or physician. No illnesses or injuries related to this recall have been reported.
The recalled product
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 (16)
- Batch No: IA10082
- IA10083
- IA10084
- IA10085
- IA10086
- exp. date 01/2023
- IA10122
- IA10123
- IA10124
- IA10125
- IA10126
- IA10127
- IA10128
- IA10129
- IA10130
- exp. date 02/2023
Distribution
Distributed nationwide across the United States.
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