FDA Recall
Terminated
Historical recordClass I
Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By: Fikrysz (M) Sdn. Bhd., Kedah, Malaysia, UPC 9 557205 060083.
by Brian P. Richardson
- Reason
- Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared sildenafil and tadalafil, two FDA approved drugs for the treatment of male erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle (NDC 0093-4150-79), Rx Only, Manufactured in Canada By: Teva Canada Limited Toronto, Canada, M1B2K9, Manufactured For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454.
by Teva Pharmaceuticals USA
- Reason
- Subpotent Product: assay results for Amoxicillin were below the specification limits.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Prostaglandin Tri-Mix 30:30:1 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
- Reason
- Lack of sterility assurance.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Prostaglandin Tri-Mix 20:25:1 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
- Reason
- Lack of sterility assurance.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Prostaglandin Tri-Mix 8.33:22.5:0.833 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
- Reason
- Lack of sterility assurance.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Prostaglandin Tri-Mix 2.5:7.5:0.25 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
- Reason
- Lack of sterility assurance.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Prostaglandin Tri-Mix 5:15:0.5 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
- Reason
- Lack of sterility assurance.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenol 10% Injection, 5 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
- Reason
- Lack of sterility assurance.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Papaverine 30 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
- Reason
- Lack of sterility assurance.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Papaverine 30 mg/Phentolamine 0.5 mg/mL, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
- Reason
- Lack of sterility assurance.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
HCG 11,00Units/B 12 11,000 mcg Injection, 30 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
- Reason
- Lack of sterility assurance.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Estrone 5mg/mL Oil Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
- Reason
- Lack of sterility assurance.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Heparin 10 mL/Marcaine 0.25% 20 mL/Sodium Bicarbonate 40 mL/Normal Saline 5 mL per 75 mL, 60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
- Reason
- Lack of sterility assurance.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Gentamicin 240 mg/500 mL Sterile Water for Irrigation,60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
- Reason
- Lack of sterility assurance.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Gentamicin 160 mg/1000 mL Sterile Water for Irrigation,1000 mL Bottle, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
- Reason
- Lack of sterility assurance.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Heparin 20,000U/Marcaine 0.25%, 10 mL, Sodium Bicarbonate 8.4% 48 mL, 60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
- Reason
- Lack of sterility assurance.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sodium Bicarbonate 8.4% Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
- Reason
- Lack of sterility assurance.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
EDTA 1% Sterile Injection (Preservative Free), Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
- Reason
- Lack of sterility assurance.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lidocaine 1%/Dextrose 12.5% (PF) Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
- Reason
- Lack of sterility assurance.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Neomycin 40 mg/Polymixin B 200,000 Bladder Irrigation Solution, 1000 mL bottle, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
- Reason
- Lack of sterility assurance.
- Published
- April 24, 2019
- 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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