Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC 0487-9003-60. A
FDA device recall Z-2053-2016 · posted 2016-06-27 · Terminated
Recall details
- Recalling firm
- Nephron Pharmaceuticals Corp.
- Reason for recall
- Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial.
- 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
- Root cause
- Process control
- Status
- Terminated
- Product code
- CAF
- Quantity affected
- 11,208 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
- Date initiated
- 2015-11-16
- Date posted
- 2016-06-27
- Date terminated
- 2017-01-09
- Location
- Orlando, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML (K120051) | Nephron Pharmaceuticals Corp. | 2012-04-20 |