| Dec 15, 2022 |
Easy Clean 75% Ethyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 918... |
cGMP Deviations |
Class II |
Frenda Corporation |
| Dec 15, 2022 |
Easy Clean 70% Isopropyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8... |
cGMP Deviations |
Class II |
Frenda Corporation |
| Dec 15, 2022 |
Global Care Antibacterial Hand Sanitizer Alcohol Etilico 70% Original, 1 Gall... |
cGMP Deviations |
Class II |
Frenda Corporation |
| Dec 15, 2022 |
Easy Clean Antiseptic Hand Sanitizer Solution 65% with Glycerine, 1 Gallon (1... |
cGMP Deviations |
Class II |
Frenda Corporation |
| Dec 12, 2022 |
Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged... |
cGMP Deviations |
Class II |
Atlantic Management Resources Ltd. |
| Dec 12, 2022 |
Menastil, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g... |
cGMP Deviations |
Class II |
Atlantic Management Resources Ltd. |
| Dec 12, 2022 |
ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 ... |
cGMP Deviations |
Class II |
Atlantic Management Resources Ltd. |
| Dec 12, 2022 |
Neuroquell, A Homeopathic Drug, Calendula Oil, packaged in1/8 Fl. oz. (3.5 g)... |
cGMP Deviations |
Class II |
Atlantic Management Resources Ltd. |
| Dec 9, 2022 |
Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution,... |
CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess o... |
Class II |
NCH Life Sciences LLC |
| Dec 7, 2022 |
Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Phar... |
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. |
Class II |
Lupin Pharmaceuticals Inc. |
| Dec 7, 2022 |
Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Phar... |
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. |
Class II |
Lupin Pharmaceuticals Inc. |
| Nov 10, 2022 |
PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only... |
CGMP Deviations: Potential for cross contamination due to product carry over. |
Class II |
Nephron Sterile Compounding Center LLC |
| Nov 10, 2022 |
PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 5... |
CGMP Deviations: Potential for cross contamination due to product carry over. |
Class II |
Nephron Sterile Compounding Center LLC |
| Nov 9, 2022 |
Conzerol zero molluscum contagiosum, Homeopathic treatment for Molluscum Cont... |
CGMP deviations |
Class II |
DISCOVERY PHARMA LLC |
| Nov 5, 2022 |
Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, pack... |
CGMP Deviations: Other lots of hand sanitizer are being recalled because they were manufactured u... |
Class II |
Adam's Polishes LLC |
| Nov 2, 2022 |
Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distribut... |
cGMP deviation: discontinue of stability support for product. |
Class II |
Direct Rx |
| Oct 13, 2022 |
Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufa... |
CGMP Deviations: |
Class II |
Akorn, Inc. |
| Oct 13, 2022 |
Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bo... |
CGMP Deviations: |
Class II |
Akorn, Inc. |
| Oct 13, 2022 |
Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Ma... |
CGMP Deviations: |
Class II |
Akorn, Inc. |
| Oct 13, 2022 |
Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tub... |
CGMP Deviations: |
Class II |
Akorn, Inc. |
| Oct 13, 2022 |
Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactur... |
CGMP Deviations: |
Class II |
Akorn, Inc. |
| Oct 13, 2022 |
AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment ... |
CGMP Deviations: |
Class II |
Akorn, Inc. |
| Oct 13, 2022 |
Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) pe... |
CGMP Deviations: |
Class II |
Akorn, Inc. |
| Oct 13, 2022 |
Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reli... |
CGMP Deviations: |
Class II |
Akorn, Inc. |
| Oct 13, 2022 |
ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube... |
CGMP Deviations: |
Class II |
Akorn, Inc. |
| Oct 13, 2022 |
Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-7... |
CGMP Deviations: |
Class II |
Akorn, Inc. |
| Oct 13, 2022 |
Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, U... |
CGMP Deviations: |
Class II |
Akorn, Inc. |
| Oct 13, 2022 |
GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dro... |
CGMP Deviations: |
Class II |
Akorn, Inc. |
| Oct 13, 2022 |
Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper ... |
CGMP Deviations: |
Class II |
Akorn, Inc. |
| Oct 13, 2022 |
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, R... |
CGMP Deviations: |
Class II |
Akorn, Inc. |
| Oct 13, 2022 |
Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only... |
CGMP Deviations: |
Class II |
Akorn, Inc. |
| Oct 13, 2022 |
Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufacture... |
CGMP Deviations: |
Class II |
Akorn, Inc. |
| Oct 13, 2022 |
Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manu... |
CGMP Deviations: |
Class II |
Akorn, Inc. |
| Oct 13, 2022 |
Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per... |
CGMP Deviations: |
Class II |
Akorn, Inc. |
| Oct 13, 2022 |
Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx O... |
CGMP Deviations: |
Class II |
Akorn, Inc. |
| Oct 13, 2022 |
Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit... |
CGMP Deviations: |
Class II |
Akorn, Inc. |
| Oct 13, 2022 |
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper b... |
CGMP Deviations: |
Class II |
Akorn, Inc. |
| Oct 13, 2022 |
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL droppe... |
CGMP Deviations: |
Class II |
Akorn, Inc. |
| Oct 13, 2022 |
Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, ... |
CGMP Deviations: |
Class II |
Akorn, Inc. |
| Oct 13, 2022 |
PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%... |
CGMP Deviations: |
Class II |
Akorn, Inc. |
| Oct 13, 2022 |
Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, ... |
CGMP Deviations: |
Class II |
Akorn, Inc. |
| Oct 13, 2022 |
Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 m... |
CGMP Deviations: |
Class II |
Akorn, Inc. |
| Oct 13, 2022 |
Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufact... |
CGMP Deviations: |
Class II |
Akorn, Inc. |
| Oct 6, 2022 |
SIREtizer Hand Sanitizer (Ethyl Alcohol) 80%, packaged in a) 3.38 oz (100 mL)... |
CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. A... |
Class II |
Southwest Iowa Renewable Energy LLC |
| Oct 5, 2022 |
Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottle... |
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. |
Class II |
Aurobindo Pharma USA Inc. |
| Sep 30, 2022 |
Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged ... |
cGMP Deviations: Out of specification for assay of one of the preservative ingredients. |
Class II |
VistaPharm, Inc. |
| Sep 16, 2022 |
Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx... |
CGMP deviations: Out of specification results obtained during routine stability testing for ethan... |
Class II |
Novartis Pharmaceuticals Corporation |
| Sep 12, 2022 |
Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distrib... |
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of ef... |
Class II |
Direct Rx |
| Sep 1, 2022 |
Synergy Hand Sanitizer, Non-Sterile Solution to help reduce bacteria that can... |
CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All I... |
Class II |
SUPERIOR GLOVE WORKS, LTD. |
| Aug 31, 2022 |
Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufact... |
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scop... |
Class II |
Akorn, Inc. |