FDA Recall
Terminated
Historical recordClass II
Losartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-935-05 1000 film coated tablets NDC 64380-935-08
by Strides Pharma Inc.
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Published
- June 8, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-933-05 1000 film coated tablets NDC 64380-933-08
by Strides Pharma Inc.
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Published
- June 8, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Equate Tartar Control Plus (Eucalyptol 0.092%, Menthol 0.042%, Methyl salicylate 0.060%, Thymol 0.064%) Antiseptic Mouthrise Plus, Antigingivitis/Antiplaque, Blue Mint, 1.5 Liter (50.7 FL OZ) bottle, Distributed By: Wal-Mart Stores, Inc., Bentonville, AR 72716, UPC 6 81131 14800 9
by Vi-Jon, LLC
- Reason
- Superpotent Drug: product complaint for milky blue appearance and consistency, further investigation by the firm found the recalled lots out of specification for the four active ingredients.
- Published
- June 8, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Succinylcholine Chloride Injection, USP, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-920-05
by Nephron Sterile Compounding Center LLC
- Reason
- Lack of Assurance of Sterility
- Published
- June 8, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-924-05
by Nephron Sterile Compounding Center LLC
- Reason
- Lack of Assurance of Sterility
- Published
- June 8, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-957-10
by Nephron Sterile Compounding Center LLC
- Reason
- Lack of Assurance of Sterility
- Published
- June 8, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Pre-Filled Syringes, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-956-10
by Nephron Sterile Compounding Center LLC
- Reason
- Lack of Assurance of Sterility
- Published
- June 8, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP, 500 mL Single-Dose Container Bag, 10 x 1 IV Bag, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-543-50
by Nephron Sterile Compounding Center LLC
- Reason
- Lack of Assurance of Sterility
- Published
- June 8, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), Preservative Free, 4 mL Pre-Filled Syringe, 5 x 4 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-946-04
by Nephron Sterile Compounding Center LLC
- Reason
- Lack of Assurance of Sterility
- Published
- June 8, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ketamine Hydrochloride Injection, USP, 30 mg/3 mL (10 mg/mL), 3 mL Pre-Filled Syringe, 5 x 3 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-33
by Nephron Sterile Compounding Center LLC
- Reason
- Lack of Assurance of Sterility
- Published
- June 8, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hydromorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL), 50 mL Pre-Filled Syringe, 5 x 50 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-559-50
by Nephron Sterile Compounding Center LLC
- Reason
- Lack of Assurance of Sterility
- Published
- June 8, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-05
by Nephron Sterile Compounding Center LLC
- Reason
- Lack of Assurance of Sterility
- Published
- June 8, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL), 150 mL IV Bag, 10 x 1 IV Bag, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-523-21
by Nephron Sterile Compounding Center LLC
- Reason
- Lack of Assurance of Sterility
- Published
- June 8, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-544-10
by Nephron Sterile Compounding Center LLC
- Reason
- Lack of Assurance of Sterility
- Published
- June 8, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
8.4% Sodium Bicarbonate Injection, USP, 1 mEq/mL, 4.2 g/50 mL (84 mg/mL), 1 x 50 mL Pre-Filled Syringe, packaged in a) 10 x 1 syringe carton, b) 30 x 1 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-214-50
by Nephron Sterile Compounding Center LLC
- Reason
- Lack of Assurance of Sterility
- Published
- June 8, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
AMBI Skincare Fade Cream Oily Skin New & Improved, Net Wt. 2 OZ (56g)
by Family Dollar Stores, Llc.
- Reason
- cGMP deviations: product stored outside of labeled temperature requirements.
- Published
- June 8, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-934-05 1000 film coated tablets NDC 64380-934-08
by Strides Pharma Inc.
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Published
- June 8, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-955-10
by Nephron Sterile Compounding Center LLC
- Reason
- Lack of Assurance of Sterility
- Published
- June 8, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-902-05
by Nephron Sterile Compounding Center LLC
- Reason
- Lack of Assurance of Sterility
- Published
- June 8, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lidocaine HCl Injection, USP, 2%, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-FIlled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-949-05
by Nephron Sterile Compounding Center LLC
- Reason
- Lack of Assurance of Sterility
- Published
- June 8, 2022
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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