Drug Recall
Terminated
Historical recordClass II
HCG 23 Day, 2876 Units/4.6 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.
- Recall initiated
- April 2, 2019
- Reported by FDA
- April 24, 2019
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
HCG 20 Day Injection, 2625 Units/4 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
- Reason
- Lack of sterility assurance.
- Recall initiated
- April 2, 2019
- Reported by FDA
- April 24, 2019
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
HCG 11,000 Units, 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.
- Recall initiated
- April 2, 2019
- Reported by FDA
- April 24, 2019
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
HCG 1,000 U/mL 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.
- Recall initiated
- April 2, 2019
- Reported by FDA
- April 24, 2019
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Gentamicin 250 mg/1000 mL Irrigation, 1000 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
- Reason
- Lack of sterility assurance.
- Recall initiated
- April 2, 2019
- Reported by FDA
- April 24, 2019
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Gentamicin 120 mg/250 mL 0.9% Sodium Chloride for Irrigation, 30 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.
- Recall initiated
- April 2, 2019
- Reported by FDA
- April 24, 2019
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Estradiol Cypionate 10 mg/mL, 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.
- Recall initiated
- April 2, 2019
- Reported by FDA
- April 24, 2019
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
DMSO 50% 60 mL/Heparin 1 mL/ Sodium Bicarbonate 60 mL/ Solu-Cortef 100 mg, 41 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.
- Recall initiated
- April 2, 2019
- Reported by FDA
- April 24, 2019
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Dexamethasone 24 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.
- Recall initiated
- April 2, 2019
- Reported by FDA
- April 24, 2019
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Vancomycin 125 mg/3mL Inhalation, 3 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.
- Recall initiated
- April 2, 2019
- Reported by FDA
- April 24, 2019
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Amphotericin B 0.15% Eye Drops, 2 mL Droppers, Anderson Compounding Pharmacy 310 Bluff City Hwy Bristol, TN.
by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
- Reason
- Lack of sterility assurance.
- Recall initiated
- April 2, 2019
- Reported by FDA
- April 24, 2019
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Atropine 0.01% Eye Drops, 1 mL and 2 mL Dropper, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
- Reason
- Lack of sterility assurance.
- Recall initiated
- April 2, 2019
- Reported by FDA
- April 24, 2019
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Acetylcysteine 10% Ophthalmic Eye Drop 2 mL droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy Bristol, TN.
by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
- Reason
- Lack of sterility assurance.
- Recall initiated
- April 2, 2019
- Reported by FDA
- April 24, 2019
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By: Iso-Tex Diagnostics, Inc.; NDC 50914-7720-8.
by Iso-Tex Diagnostics, Inc
- Reason
- Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
- Recall initiated
- April 15, 2019
- Reported by FDA
- April 24, 2019
- Distribution
- TN
View recall →
Drug Recall
Terminated
Historical recordClass II
Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC 55111-0533-05), Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, - 500 090 INDIA
by Dr. Reddy's Laboratories, Inc.
- Reason
- cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
- Recall initiated
- April 11, 2019
- Reported by FDA
- April 24, 2019
- Distribution
- Product was distributed to major distributors and retailers who may have further distribute the product throughout the United States.
View recall →
Drug Recall
Terminated
Historical recordClass III
Repairwear Laser Focus Line Smoothing Cream Broad Spectrum SPF 15, packaged in a light green folding carton containing a 50 mL silver jar with a silver cap, Clinique Laboratories, Dist. New York, NY 10022
by Estee Lauder Inc
- Reason
- Defective container: Ineffective seal between the cap and jar of the affected product.
- Recall initiated
- March 15, 2019
- Reported by FDA
- April 24, 2019
- Distribution
- U.S.A. Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Dr. Berne's MSM DROPS 15% Solution, Net Wt. 30ml/1.014 OZ, Distributed by: Dr. Berne's Whole Heallth Products, 400 Hillsboro Technology Drive, Deerfield BEach, FL 33441 SKU#182 UPC 00854582001036
by MSM Nutraceuticals, LLC
- Reason
- Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
- Recall initiated
- March 12, 2019
- Reported by FDA
- April 24, 2019
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical recordClass II
Red Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Naphazolene Chloride, Net Wt. 15ml, 0.15 fl oz., Manufactured by: MSM Nutraceuticals, LLC , UPC 8 54582 00118 0
by MSM Nutraceuticals, LLC
- Reason
- Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
- Recall initiated
- March 12, 2019
- Reported by FDA
- April 24, 2019
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical recordClass II
Dry Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Polyethylene Glycon, Net Wt. 15ml, 0.51 fl oz., Manufactured by: MSM Nutraceuticals, LLC, UPC 8 54582 00119 7.
by MSM Nutraceuticals, LLC
- Reason
- Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
- Recall initiated
- March 12, 2019
- Reported by FDA
- April 24, 2019
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical recordClass II
15% MSM, Eye Drops, Net Wt. 30ml, 1.014 oz., Manufactured by: MSM Nutraceuticals, LLC 2103 West Parkside Lane, Ste.107, Phoenix, AZ 85027, UPC 8 54582 00120 3.
by MSM Nutraceuticals, LLC
- Reason
- Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
- Recall initiated
- March 12, 2019
- Reported by FDA
- April 24, 2019
- Distribution
- Nationwide in the USA
View recall →
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
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