D-0388-2016 Class II Terminated
FDA drug recall D-0388-2016 was initiated by Nephron Pharmaceuticals Corp. on August 21, 2015 and is designated Class II. Reason for recall: Discoloration The recall status is terminated (terminated February 10, 2017). Affected quantity: 47,754 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- December 9, 2015
- Initiation Date
- August 21, 2015
- Termination Date
- February 10, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 47,754 cartons
Product Description
Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator, Starter Kit (Racepinephrine 11.25 mg) 10 individual foil wrapped vials with 1 EZ Breathe Atomizer per carton, Manufactured By: nephron pharmaceuticals corporation, Orlando, FL --- NDC 0487-2784-10
Reason for Recall
Discoloration
Distribution Pattern
Nationwide
Code Information
Lots R4027A (Exp 10/31/2015), R4036A (Exp 12/31/2015)