Recall Enforment Report D-0355-2023
- NDC List
- Drug Recall Enforcement Reports
- Recall Enforcement Report: 91749
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Nephron Sterile Compounding Center LLC, originally initiated on 02-22-2023 for the product Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-997-15. The product was recalled due to lack of assurance of sterility. The product was distributed nationwide and the recall is currently completed.
Recall Enforcement Reports
Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
---|---|---|---|---|---|---|---|
D-0355-2023 | 02-22-2023 | 03-08-2023 | Class II | 4,743 bottles | Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-997-15. | Lack of Assurance of Sterility | Completed |
D-0356-2023 | 02-22-2023 | 03-08-2023 | Class II | 443,483 bottles | Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32 mcg/mL*), 250 mL Single-Dose Container, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-316-25. | Lack of Assurance of Sterility | Completed |
D-0360-2023 | 02-22-2023 | 03-08-2023 | Class II | 31,500 vials | Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-305-10. | Lack of Assurance of Sterility | Completed |
D-0357-2023 | 02-22-2023 | 03-08-2023 | Class II | 305,895 bottles | Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-319-25. | Lack of Assurance of Sterility | Completed |
D-0362-2023 | 02-22-2023 | 03-08-2023 | Class II | 10,980 bottles | Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-321-25. | Lack of Assurance of Sterility | Completed |
D-0359-2023 | 02-22-2023 | 03-08-2023 | Class II | 546,450 vials | Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-302-10. | Lack of Assurance of Sterility | Completed |
D-0358-2023 | 02-22-2023 | 03-08-2023 | Class II | 270,291 bottles | Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-315-25. | Lack of Assurance of Sterility | Completed |
D-0361-2023 | 02-22-2023 | 03-08-2023 | Class II | 24,870 vials | Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-301-10. | Lack of Assurance of Sterility | Completed |
Recall Enforcement Report D-0355-2023
Recall Enforcement Report D-0356-2023
Field Name | Field Value |
---|---|
Event ID | 91749 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
Recall Number | D-0356-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
Recall Classification | 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 What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
Distribution Pattern | Nationwide in the USA What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
Product Description | Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32 mcg/mL*), 250 mL Single-Dose Container, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-316-25. |
Reason For Recall | Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective. |
Product Quantity | 443,483 bottles Product Quantity The amount of product subject to recall. |
Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
Report Date | 03-08-2023 |
Recall Initiation Date | 02-22-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
Initial Firm Notification | Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
Product Type | Drugs |
Recalling Firm | Nephron Sterile Compounding Center LLC |
Code Info | Lots: NB2015A, Exp. 02/27/2023; NB2016A, Exp. 02/19/2023; NB2021A, Exp. 03/05/2023; NB2023A, Exp. 03/12/2023; NB2026A, Exp. 03/29/2023; NB2029A, Exp. 04/21/2023; NB2031A, Exp. 04/21/2023; NB2033A, Exp. 05/10/2023; NB2034A, Exp. 05/19/2023; NB2037A, Exp. 05/25/2023; NB2039A, Exp. 06/05/2023; NB2041A, Exp. 06/14/2023; NB2044A, Exp. 06/18/2023; NB2050A, Exp. 07/19/2023; NB2054A, Exp. 08/04/2023; NB2057A, Exp. 08/12/2023; NB2059A, Exp. 08/20/2023; NB2061A, Exp. 09/14/2023; NB2067A, Exp. 09/22/2023 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
Status | Completed - A recall which has reached the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections. |