Nephron Pharmaceuticals recalls
Nephron Pharmaceuticals appears in 16 official U.S. recall notices indexed by RecallRadar, most recently on 2019-11-06.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 16 |
|---|---|
| Published | 2012-08-15 to 2019-11-06 |
| By agency | FDA Drug (11), FDA Device (5) |
| By classification | Class II (12), Class I (3), Class III (1) |
| By status | terminated (16) |
| Distribution named in notices | 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, US, UT, VA, VT, WA, WI, WV |
Recalls
- PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, Single-Dose Container, 5 x 10 mL pre-filled syringes, Nephron…
FDA Drug · Class III · 2019-11-06 · Nephron Pharmaceuticals
Reason: Incorrect labeling: Incorrect or missing lot and/or exp date - Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl
FDA Drug · Class II · 2019-10-30 · Nephron Pharmaceuticals
Reason: Lack of Assurance of Sterility; bags have potential to leak - PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chloride Injection-250 mL Total Dose: (500 mcg/156.3 mg)/250 mL, Rx…
FDA Drug · Class II · 2019-10-30 · Nephron Pharmaceuticals
Reason: GMP Deviations: potential glass contamination - PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride Injection-250 mL, Rx Only Total Dose: (500 mcg/312.5 mg)/250…
FDA Drug · Class II · 2019-10-30 · Nephron Pharmaceuticals
Reason: GMP Deviations: potential glass contamination - PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride Injection-200 mL Total Dose: (400 mcg/200 mg)/200 mL, Rx Only…
FDA Drug · Class II · 2019-10-30 · Nephron Pharmaceuticals
Reason: GMP Deviations: potential glass contamination - del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Colu…
FDA Drug · Class II · 2019-10-30 · Nephron Pharmaceuticals
Reason: Lack of Assurance of Sterility; bags have potential to leak - Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only, NDC 0487-9007-60
FDA Device · Class II · 2016-07-06 · Nephron Pharmaceuticals
Reason: Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial. - Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC 0487-9003-60
FDA Device · Class II · 2016-07-06 · Nephron Pharmaceuticals
Reason: Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial. - Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator, Starter Kit (Racepinephrine 11.25 mg) 10 individual foil wrapped vials with…
FDA Drug · Class II · 2015-12-09 · Nephron Pharmaceuticals
Reason: Discoloration - Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator Refills (Racepinephrine USP 11.25 mg), 30 individual foil wrapped vials per…
FDA Drug · Class II · 2015-12-09 · Nephron Pharmaceuticals
Reason: Discoloration - Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials, a) 30 count (NDC 04…
FDA Drug · Class II · 2015-10-21 · Nephron Pharmaceuticals
Reason: Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process - Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation Only, Rx Only, 25 x 3 mL Sterile Unit-Dose Vials per carton,…
FDA Drug · Class II · 2013-10-30 · Nephron Pharmaceuticals
Reason: Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit. - AsthmaNefrin Starter Kit contains ten (10) AsthmaNefrin vials and one (1) EZ Breathe Atomizer
FDA Device · Class I · 2013-06-05 · Nephron Pharmaceuticals
Reason: Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard. - EZ Breathe Atomizer Model # EZ-100
FDA Device · Class I · 2013-06-05 · Nephron Pharmaceuticals
Reason: Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard. - EZ Breathe Medication Cup
FDA Device · Class I · 2013-06-05 · Nephron Pharmaceuticals
Reason: Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard. - Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials) per carton…
FDA Drug · Class II · 2012-08-15 · Nephron Pharmaceuticals
Reason: Lack of Assurance of Sterility