Drugs & Medicine Recalls
Pharmaceutical recall notices, chemical impurities, and biological contamination.
Mojo Max Fusion XXX, 500 mg, one capsule per blister card, 20 count box, Distrib...
Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).
Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Val...
Lack of Assurance of Sterility
Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactur...
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b...
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactur...
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes,...
CGMP Deviations
Wipes Plus, Hand Sanitizing Alcohol Free BZK Wipes (Benzalkonium Chloride 0.13%)...
CGMP Deviations
FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bo...
Stability Data Does Not Support Expiry Date.
MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5" x7", 1000 ea Bulk, M...
CGMP Deviations
Max Packaging Antibacterial Towelette (Benzalkonium Chloride 0.13%), 1 towelette...
CGMP Deviations
First Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%), 5x7, bulk...
CGMP Deviations
Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx onl...
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
1) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5"x7" Piedmont Sanit...
CGMP Deviations
Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 pack...
CGMP Deviations
Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 1000 per case, Acme United ...
CGMP Deviations
Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, ND...
Presence of Particulate Matter: Due to production issues
Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Va...
Lack of Assurance of Sterility
MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz...
Stability Data Does Not Support Expiry Date.
Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 packe...
CGMP Deviations
Antimicrobial Alcohol Hand Wipe, Isopropyl Alcohol 70%, Manufactured for : Custo...
CGMP Deviations
Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) 1000 Packs per case...
CGMP Deviations
Cleansing Towelette (Benzalkonium Chloride 0.13%), 5"x 7", 1,000 case/Bulk, Med-...
CGMP Deviations
Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bott...
Failed Dissolution Specifications