CLASS II Drug recall · Reported 12 Oct 2022 · FDA Enforcement Report
Arformoterol Tartrate Inhalation Solution, 15 mcg/ Sterile Unit-Dose recalled
Cipla is recalling Arformoterol Tartrate Inhalation Solution, 15 mcg/ Sterile Unit-Dose, distributed nationwide in the US. The recall was initiated on 29 Sep 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1550-2022
- FDA event ID
- 90920
- Recalling firm
- Cipla, Warren, NJ
- Manufacturer
- Cipla USA Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Sep 2022
- FDA classified
- 30 Sep 2022
- Reported
- 12 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 29 Sep 2022 | Recall initiated by company | |
| 30 Sep 2022 | Classified by FDA | +1 day |
| 12 Oct 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: environmental monitoring failure.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dose Vials per pouch, NDC 69097-168-48; 60 (12 x 5) x 2 mL Sterile Unit-Dose Vials per carton, NDC 69097-168-64, Rx Only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059.
Where it was distributed
Product was distributed nationwide to distributors/wholesalers who may have further distributed the product.
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: environmental monitoring failure.
Which lots are affected?
Batch No: IA10082, IA10083, IA10084, IA10085, IA10086, exp. date 01/2023; IA10122, IA10123, IA10124, IA10125, IA10126, IA10127, IA10128, IA10129, IA10130, exp. date 02/2023
Where was it sold?
Product was distributed nationwide to distributors/wholesalers who may have further distributed the product.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Cipla
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|---|---|---|---|---|---|
| Drug | CLASS II | Phytonadione Injectable Emulsion, USP 10mg/mL recalled by CiplaPhytonadione | Cipla | Potency & Assay | Nationwide |
| Drug | CLASS II | Budesonide Inhalation Suspension 0.25mg/, For Inhalation Only recalledBudesonide | Cipla | Sterility | Nationwide |
| Drug | CLASS II | Difluprednate Ophthalmic Emulsion recalled by CIPLADifluprednate | Cipla | Sterility | Nationwide |
| Drug | CLASS II | Difluprednate Ophthalmic Emulsion recalled by CIPLA | Cipla | Sterility | Nationwide |
| Drug | CLASS II | Difluprednate Ophthalmic Emulsion recalled by CIPLADifluprednate | Cipla | Sterility | Nationwide |
Other Arformoterol recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Arformoterol Tartrate Inhalation Solution 15 mcg*/ For Oral recalled | Glenmark Pharmaceuticals Inc., USA | Sterility | Nationwide |