Class II · Moderate risk Ongoing
Estradiol Cypionate 10mg/mL, a) 1mL-vial, b) 2 mL-vial, Room Temperature, Tailor Made Compounding
Reason Lack of Assurance of Sterility
FDA Drug Recalls
2,661 recalls, newest first
Class II · Moderate risk Ongoing
Dexpanthenol Preservative Free 250mg/mL, 2mL-vial, Room Temperature, Tailor Made Compounding
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Dexpanthenol 250mg/mL, 30mL-vial, Room Temperature, Tailor Made Compounding
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Calcium Chloride Preservative Free, 100mg/mL, a) 5 mL-vial, b) 30 ml-vial, Room Temperature, Tailor Made Compounding
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Biotin 5mg/mL, 5mL-vial, Refrigerate, Tailor Made Compounding
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
BCAAs (Leucine/Iso-Leucine/Valine) 10mg/10mg/5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Ascorbic Acid 500mg/mL, a) 25 ml-vial, b) 50 ml-vial, Refrigerate, Tailor Made Compounding
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Anastrozole/Testosterone Cypionate/Propionate 1mg/160mg/40mg/mL, 10 mL-vial, Room Temperature, Tailor Made Compounding
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Alprostadil/Papaverine/Phentolamine 60mcg/30mg/3mg/mL, 3mL-vial, Refrigerate, Tailor Made Compounding
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Alpha Lipoic Acid 25mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
All Over-The-Counter (OTC) drug products sold by Family Dollar retail stores located in Alabama, Arkansas, Louisiana…
Reason CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center.
Class I · High risk Ongoing
Sure Regular Antiperspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%), packaged in 6 oz (170 g) aerosol cans, Distributed by…
Reason Chemical contamination: Presence of benzene
Class I · High risk Ongoing
Sure Unscented Anti-perspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%), packaged in 6 oz (170 g) aerosol cans, Distributed…
Reason Chemical contamination: Presence of benzene
Class I · High risk Ongoing
Brut Classic Antiperspirant & Deodorant (aluminum chlorohydrate 20.9%) packaged in a) 4 oz. (113g) aerosol cans (UPC…
Reason Chemical contamination: Presence of benzene
Class II · Moderate risk Ongoing
Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1PT) 473 ML bottle, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ…
Reason Labeling - product contains undeclared ethyl alcohol
Class II · Moderate risk Ongoing
70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen, 12 FL. OZ. 355 ML bottle, Distributed By: TSM Brands LLC, 540…
Reason Labeling - product contains undeclared ethyl alcohol
Class II · Moderate risk Ongoing
Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharmaceuticals Inc…
Reason Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that…
Class II · Moderate risk Ongoing
Premium Nature Instant Hand Sanitizer, (ethyl alcohol 70%), plastic bottle packaged as (a) 8 OZ, UPC 8 19192 02866 8; (b) 16 OZ…
Reason Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Class II · Moderate risk Ongoing
Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), plastic bottles packaged as (a) 2 OZ / 60ML, UPC 8 19192 02865 1; (b)…
Reason Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Class II · Moderate risk Ongoing
Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville, NC 27834…
Reason CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.
Class II · Moderate risk Ongoing
Medroxyprogesterone Acetate Injection, IM, 150 mg/mL, packaged in 1 ml Single Dose Vial, RX Only, Ideal Pharmacy, 2333 Morris…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
NaturesPlus Advanced Therapeutics Glucosamine Chondroitin MSM Ultra Rx- Joint Cream, 4 oz tubes, Manufactured for NaturesPlus 548…
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCT: microbial contaminant identified as Pluralibacter gergoviae.
Class II · Moderate risk Ongoing
Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by…
Reason Superpotent Drug: Minimally superpotent
Class I · High risk Ongoing
Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by…
Reason Superpotent Drug
Class II · Moderate risk Ongoing
Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred…
Reason Defective container: Out of specification for container integrity leading to bottles leaking.