Class II · Moderate risk
Albuterol Sulfate Inhalation Solution
Labelling: Illegible label
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials ( 6 pouches of 5 - 3 mL vials), Rx only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-173-53
Affected NDC
69097-0173-53
Compare with the code on your package — it is the most precise check available.
Drug: Albuterol
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Ipratropium Bromide and Albuterol Sulfate NDC 69097-0173 |
ALBUTEROL SULFATE 2.5 mg/3mL; IPRATROPIUM BROMIDE .5 mg/3mL | Solution Respiratory (inhalation) |
Cipla USA Inc. | Rx |
- Recalling firm
- Cipla USA, Inc.
- NDC code
- 69097-173-53
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0471-2024 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Albuterol recalls
See all
Class III · Low risk
Albuterol Sulfate
Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
Class II · Moderate risk
Airsupra (albuterol and budesonide)
Defective delivery system
Class I · High risk
Albuterol Sulfate Inhalation Aerosol
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Class II · Moderate risk
Albuterol Sulfate Syrup
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Other recalls by Cipla USA, Inc.
All 2024 recalls
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
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