Class II · Moderate risk Terminated
Conzerol zero molluscum contagiosum, Homeopathic treatment for Molluscum Contagiosum, Topical Cream, Net weight 0.78 oz (22g)…
Reason CGMP deviations
FDA Drug Recalls
17,898 recalls, newest first
Class III · Low risk Terminated
Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [100 or 1000 ] Capsules per bottle, Distributed by…
Reason Failed Impurity/Degradation Specifications
Class III · Low risk Terminated
Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1000 Capsules per bottle, Distributed by: Lannett…
Reason Failed Impurity/Degradation Specifications
Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045…
Reason Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
Class II · Moderate risk Terminated
Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, Imprimis Rx, Ledgewood, NJ.
Reason Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost.
Class II · Moderate risk Ongoing
Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC…
Reason CGMP Deviations: Other lots of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to…
Class I · High risk Ongoing
Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC…
Reason Chemical Contamination: FDA analysis found 1 lot of Adam's Polishes ALCOHOL BASED HAND SANITIZER isopropyl alcohol 75% v/v to contain methanol.
Class II · Moderate risk Terminated
Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive…
Reason cGMP deviation: discontinue of stability support for product.
Class II · Moderate risk Terminated
Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India…
Reason Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.
Class III · Low risk Terminated
Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo single-dose vial and One Susvimo…
Reason Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue…
Class II · Moderate risk Terminated
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx only, Distributed by: Sun Pharmaceutical…
Reason Presence of Foreign Substance
Class II · Moderate risk Ongoing
Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045…
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL…
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL dropper…
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube, Manufactured by: Akorn, Inc., Lake Forest, IL…
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest…
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Distributed by: Akorn Operating…
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25%, 15 mL per dropper bottle, Rx only…
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045…
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, Manufactured by…
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045…
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL (0.17 FL OZ) per bottle, Manufactured by…
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL…
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045…
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP, Net Wt. 3.5 g (1/8 oz.), Rx Only, Manufactured…
Reason CGMP Deviations: