Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only, Manufactured by: Cipla Ltd, Indore SE Z, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ, 07059, NDC 69097-142-60
Reported: July 19, 2023 Initiated: June 27, 2023 #D-0938-2023
Product Description
Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only, Manufactured by: Cipla Ltd, Indore SE Z, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ, 07059, NDC 69097-142-60
Reason for Recall
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Details
- Recalling Firm
- Cipla USA, Inc.
- Units Affected
- 278,538 canisters
- Distribution
- Nationwide in the US
- Location
- Warren, NJ
Frequently Asked Questions
What product was recalled? ▼
Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only, Manufactured by: Cipla Ltd, Indore SE Z, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ, 07059, NDC 69097-142-60. Recalled by Cipla USA, Inc.. Units affected: 278,538 canisters.
Why was this product recalled? ▼
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 19, 2023. Severity: Critical. Recall number: D-0938-2023.
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