Multi-event October 2019 FDA Recall Drug by Nephron Pharmaceuticals Corporation Dba Nephron Sterile Compounding Center
This Multi-event Class II drug recall was voluntarily initiated by Nephron Pharmaceuticals Corporation Dba Nephron Sterile Compounding Center on October 9, 2019 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility; bags have potential to leak. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0151-2020
Lack of Assurance of Sterility; bags have potential to leak
10-09-2019
10-30-2019
1047 bags
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
12-01-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-984-10
Batch or Lot Expiration Information
Lot# Lots: NC9048A Exp. 10/14/2019; NC9048B Exp. 10/14/2019; NC9049A Exp. 10/16/2019; NC9049B Exp. 10/16/2019; NC9051A Exp. 10/21/2019; NC9051B Exp. 10/21/2019; NC9052A Exp. 10/22/2019; NC9052B Exp. 10/22/2019; NC9053A Exp. 10/23/2019; NC9053B Exp. 10/23/2019; NC9054A Exp. 10/28/2019; NC9054B Exp. 10/28/2019; NC9055A Exp. 10/30/2019; NC9056B Exp. 11/04/2019
Recall Number: D-0150-2020
Lack of Assurance of Sterility; bags have potential to leak
10-09-2019
10-30-2019
162 bags
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
12-01-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-988-10
Batch or Lot Expiration Information
Lot# Lots: AA9023A Exp. 10/24/2019; AA9023B Exp. 10/24/2019
