Why it was recalled
Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed.
Product description
CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4% a) 30 mL SINGLE DOSE VIAL, (NDC 0517-2930-25), b) 100 mL PHARMACY BULK PACKAGE (NDC 0517-2900-25), Rx Only, AMERICAN REGENT, INC. SHIRLEY, NY 11967.
Lot numbers, UPCs & expiration codes
30 mL Lots: 9198, 9252, 9299, 9305, 9402, 9423, 9432, 9553, 9595, 9646, 9681, 9737, 9797, 9831, 0051, 0095, 0362; 100 mL Lots: 9225, 9492, 9711, 0007, 0058
Where it was sold
Nationwide, Puerto Rico, and Abu Dhabi
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-1378-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 15, 2011
- FDA report date
- Jun 20, 2012
- Quantity
- 30 mL: 2,078,800 vials; 100 mL: 167,100 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Luitpold Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1378-2012, exactly as published.
Show all FDA fields
- City
- Shirley
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 58410
- Address
- One Luitpold Drive
- Address (line 2)
- P.O. Box 9001
- Code information
- 30 mL Lots: 9198, 9252, 9299, 9305, 9402, 9423, 9432, 9553, 9595, 9646, 9681, 9737, 9797, 9831, 0051, 0095, 0362; 100 mL Lots: 9225, 9492, 9711, 0007, 0058
- Postal code
- 11967-9001
- Report date
- Jun 20, 2012
- Product type
- Drugs
- Recall number
- D-1378-2012
- Classification
- Class II
- Recalling firm
- Luitpold Pharmaceuticals, Inc.
- Product quantity
- 30 mL: 2,078,800 vials; 100 mL: 167,100 vials
- Termination date
- Jun 28, 2018
- Reason for recall
- Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4% a) 30 mL SINGLE DOSE VIAL, (NDC 0517-2930-25), b) 100 mL PHARMACY BULK PACKAGE (NDC 0517-2900-25), Rx Only, AMERICAN REGENT, INC. SHIRLEY, NY 11967.
- Distribution pattern
- Nationwide, Puerto Rico, and Abu Dhabi
- Recall initiation date
- Mar 15, 2011
- Initial firm notification
- Press Release
- Center classification date
- Jun 14, 2012