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 →
FDA Recall
Terminated
Historical recordClass II
Ketamine Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 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: 69374-982-55
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, 6 mg/30 mL (0.2 mg/mL), 30 mL Pre-Filled Syringe, 5 x 30 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-529-30
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, 0.6 mg/3 mL (0.2 mg/mL), Preservative Free, 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: 69374-903-03
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, 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: 69374-925-10
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
Calcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL, 1 g/10 mL (100 mg/mL), 10 mL Pre-Filled Syringe, 5 x 10 Pre-filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-950-10
by Nephron Sterile Compounding Center LLC
- Reason
- Lack of Assurance of Sterility
- Published
- June 8, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Walnut Creek Chocolate Co Inc
- Product
- Dutch Delight Peanut Butter Cup packaged as 10 piece or 10o…
- Reason
- Potential Salmonella contamination
- Published
- June 8, 2022
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Walnut Creek Chocolate Co Inc
- Product
- Jason & Mary Large Dark Peanut Butter Cup
- Reason
- Potential Salmonella contamination
- Published
- June 8, 2022
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Walnut Creek Chocolate Co Inc
- Product
- Assorted Creams packaged in 8oz and 16oz boxes
- Reason
- Potential Salmonella contamination
- Published
- June 8, 2022
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Walnut Creek Chocolate Co Inc
- Product
- Assorted Chocolate Heart Boxes packaged in 8oz and 16oz box…
- Reason
- Potential Salmonella contamination
- Published
- June 8, 2022
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Walnut Creek Chocolate Co Inc
- Product
- Jason & Mary Peanut Butter Pretzel Cluster
- Reason
- Potential Salmonella contamination
- Published
- June 8, 2022
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Walnut Creek Chocolate Co Inc
- Product
- Ritz Peanut Butter
- Reason
- Potential Salmonella contamination
- Published
- June 8, 2022
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Walnut Creek Chocolate Co Inc
- Product
- Peanut Butter Fudge packaged in 8oz tub, 5lb loaf, 4lb tra…
- Reason
- Potential Salmonella contamination
- Published
- June 8, 2022
- Distribution
- Multiple states
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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