Why it was recalled
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Product description
Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10, Indure, SEZ, Pithampur, M.P.-454 775, INDIA, Manufactured for: Dr. Reddy's Laboratories, Inc., Princeton NJ 08640. NDC: 43598-412-25.
Lot numbers, UPCs & expiration codes
Lot #: FA4022; Expiry: December 2015.
Where it was sold
U.S. Nationwide including Puerto Rico.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1078-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 24, 2015
- FDA report date
- May 20, 2015
- Quantity
- 140,625 Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cipla Limited
Original FDA data
Every field from FDA enforcement report D-1078-2015, exactly as published.
Show all FDA fields
- City
- Pithampur, District Dhar
- Status
- Terminated
- Country
- India
- Event ID
- 71133
- Address
- Plot No. 9 & 10 Pharma Zone Phase II
- Address (line 2)
- Section III Indore Special Economic Zone
- Code information
- Lot #: FA4022; Expiry: December 2015.
- Report date
- May 20, 2015
- Product type
- Drugs
- Recall number
- D-1078-2015
- Classification
- Class III
- Recalling firm
- Cipla Limited
- Product quantity
- 140,625 Vials
- Termination date
- Feb 14, 2017
- Reason for recall
- Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10, Indure, SEZ, Pithampur, M.P.-454 775, INDIA, Manufactured for: Dr. Reddy's Laboratories, Inc., Princeton NJ 08640. NDC: 43598-412-25.
- Distribution pattern
- U.S. Nationwide including Puerto Rico.
- Recall initiation date
- Apr 24, 2015
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- May 14, 2015