Recall Z-2054-2016
Nephron Pharmaceuticals Corp. · initiated November 16, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only, NDC 0487-9007-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. For respiratory therapy, Solium Chloride Inhalation Solution USP, 3% is used in conjunction with a nebulizer
Codes / lots: Lot Number N4753A, Exp 11/16
Reason for recall
Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial.
FDA-determined cause: Process control
Action taken
Nephron Pharmaceuticals Corporation sent an Urgent Drug Recall letter to all affected customers on November 16, 2015. The letter identified the product, the problem, and the action to be taken by the customer. NPC requested customers remove the affected lots from their inventory, including store shelves. Customers with questions should call 1-844-374-6841
Details
- Recall number
- Z-2054-2016
- Initiated
- November 16, 2015
- Posted by FDA
- June 27, 2016
- Terminated
- January 9, 2017
- Product code
- CAF – Nebulizer (Direct Patient Interface)
- Quantity
- 13,692 cartons
- Distribution
- Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, FL, GA, IL, KY, LA, MA, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV and Internationally to Canada.
- Recalling firm
- Nephron Pharmaceuticals Corp., Orlando, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2053-2016 Class II | Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per…Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial. | 11/16/2015Terminated |