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 II
Natural Organics, Inc.
- Product
- Keto Living Sugar Control
- Reason
- Contains undeclared wheat (gluten) in product labeled "gluten free"
- Published
- June 8, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Amino Blend Glutamine 30 mg/mL Ornithine HCL 50 mg/mL Arginine HCL 100 mg/mL Lysine HCL 50 mg/mL Citrulline 50 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835.NDC 73198-0129-30.
by Olympia Compounding Pharmacy dba Olympia Pharmacy
- Reason
- Lack of assurance of sterility.
- Published
- June 1, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
QM-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 150 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0019-10.
by Olympia Compounding Pharmacy dba Olympia Pharmacy
- Reason
- Lack of assurance of sterility.
- Published
- June 1, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
QM-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 60 mcg/mL Atropine 0.2 mg/mL Multi-Dose 10 mL Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0018-10.
by Olympia Compounding Pharmacy dba Olympia Pharmacy
- Reason
- Lack of assurance of sterility.
- Published
- June 1, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Pyridoxine HCL 100 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0066-30.
by Olympia Compounding Pharmacy dba Olympia Pharmacy
- Reason
- Lack of assurance of sterility.
- Published
- June 1, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Phenylephrine 1 mg/mL, Multi-Dose 5 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0021-05.
by Olympia Compounding Pharmacy dba Olympia Pharmacy
- Reason
- Lack of assurance of sterility.
- Published
- June 1, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
PGE-3 Alprostadil 150 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0030-10.
by Olympia Compounding Pharmacy dba Olympia Pharmacy
- Reason
- Lack of assurance of sterility.
- Published
- June 1, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Ondansetron Hydrochloride, 1 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0127-30.
by Olympia Compounding Pharmacy dba Olympia Pharmacy
- Reason
- Lack of assurance of sterility.
- Published
- June 1, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Olympia Vita-Complex Thiamine HCL (B1) 100 mg/mL Niacinamide (B3) 100 mg/mL Riboflavin 5 P04 (B2) 2 mg/mL Dexpanthenol (B5) 2 mg/mL Pyridoxine HCL (B6) 2 mg/mL Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0063-30.
by Olympia Compounding Pharmacy dba Olympia Pharmacy
- Reason
- Lack of assurance of sterility.
- Published
- June 1, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Olympia Mineral Blend Magnesium Chloride 80 mg/mL Zinc Sulfate 1 mg/mL Manganese Sulfate 20 mcg/mL Copper Gluconate 0.2 mg/mL Sodium Selenite 18 mcg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0061-30.
by Olympia Compounding Pharmacy dba Olympia Pharmacy
- Reason
- Lack of assurance of sterility.
- Published
- June 1, 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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