Class II · Moderate risk Ongoing
Children's Healthcare of Atlanta, Instant Hand Sanitizing Wipe(Benzalkonium Chloride 0.13%), 1000 per case, Made in USA for Food…
Reason CGMP Deviations
FDA Drug Recalls
454 recalls, newest first
Class II · Moderate risk Ongoing
Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 packets, 5x7, Manufactured for Dynarex Corporation…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets, 5x7, Manufactured for Dynarex Corporation, 10…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%), 25 wipes per box, Distributed by Green Guard, St. Louis, MO 63045…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 1000 per case, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
WP WipesPlus Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 5x7, 100 CT, Progressive Products, 211 S. Ridge Street, Rye…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Med-Nap Cleansing Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Cleansing Towelette (Benzalkonium Chloride 0.13%), 5"x 7", 1,000 case/Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 packets, 5" x 7", Manufactured for Dynarex…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Wipes Plus, Hand Sanitizing Alcohol Free BZK Wipes (Benzalkonium Chloride 0.13%), Manufactured for: CFS Brands DBA WipesPlus…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5" x7", 1000 ea Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Medi-First Antiseptic Wipes (BZK)(Benzalkonium Chloride 0.13%), 100 wipes per box, Manufactured for Medique Products, Fort…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Savannah Antibacterial Towelettes (Benzalkonium Chloride 0.13%), 1 towelette, 4 x 7, R&R Enterprise, NDC 59647-749-02
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Max Packaging Antibacterial Towelette (Benzalkonium Chloride 0.13%), 1 towelette, 4x7, Max Packaging, Made in the USA, NDC…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
1) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5"x7" Piedmont Sanitizing Hand Wipes, 1,000 ea Bulk, Made in USA for…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
First Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%), 5x7, bulk, Acme United Corporation, 2280 Tanner Road…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) 1000 Packs per case, Manufactured For: Dukal, LLC, Ronkonkoma, NY…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 50 Wipes, NDC 0924-7116-03.
Reason CGMP Deviations
Class II · Moderate risk Ongoing
First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 100 Wipes, NDC 0924-7116-04
Reason CGMP Deviations
Class I · High risk Ongoing
UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma…
Reason Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment…
Class II · Moderate risk Ongoing
Thyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ…
Reason Subpotent Drug
Class II · Moderate risk Ongoing
methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton containing 21 Tablets, Rx only, Distributed by…
Reason Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing…
Class II · Moderate risk Ongoing
Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug product…
Reason Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Class II · Moderate risk Ongoing
Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc…
Reason Superpotent and Subpotent