Drug recalls
500 recallsBromfenac Ophthalmic Solution 0.07%, 3 ml, Rx only, Sterile
ALEMBIC PHARMACEUTICALS, INC.
Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e.
Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only
Appco Pharma LLC
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin im…
EYE DROPS Advanced Relief, (dextran 70 0.1%
K.C. Pharmaceuticals, Inc
Lack of Assurance of Sterility
Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%)
K.C. Pharmaceuticals, Inc
Lack of Assurance of Sterility
STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and…
K.C. Pharmaceuticals, Inc
Lack of Assurance of Sterility
Octreotide Acetate for Injectable Suspension
Teva Pharmaceuticals USA, Inc
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food…
Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle
MACLEODS PHARMA USA, INC
Subpotent Drug
Octreotide Acetate for Injectable Suspension
Teva Pharmaceuticals USA, Inc
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food…
Octreotide Acetate for Injectable Suspension
Teva Pharmaceuticals USA, Inc
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food…
Meclizine Hydrochloride Tablets, USP 12.5 mg
Amerisource Health Services LLC
Failed tablet specifications.
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (cont…
Radnostix
Failed Tablet/Capsule Specifications
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension
Chiesi USA, Inc.
Lack of Assurance of Sterility
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*
Apotex Corp.
Lack of Assurance of Sterility
Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL
STRIDES PHARMA INC
Presence of foreign substance: the firm received complaints for a gel-like mass and black particl…
Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only
Annora Pharma Private Limited
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin…
Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply
Cardinal Health 200, LLC
Non-Sterility: microbial contamination identified as Paenibacillus phoenicis
Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL
SOMERSET THERAPEUTICS LLC
Failed Impurities/Degradation Specifications - OOS impurities result observed during long term st…
Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only
Zydus Pharmaceuticals (USA) Inc
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidiz…
Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only
Cipla USA, Inc.
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condit…
Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%)
ACME UNITED CORPORATION
CGMP Deviations
Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7
ACME UNITED CORPORATION
CGMP Deviations
Midodrine Hydrochloride Tablets, USP, 5 mg
The Harvard Drug Group LLC
Defective container;
Semaglutide, For Rx compounding use only, packaged in a) 1g
Harbin Jixianglong Biotech Co., Ltd.
CGMP Deviations This recall has been initiated due to failing to complete process validation and…
Product label: Temozolomide Capsules, 5mg
Rising Pharma Holding, Inc.
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-…
First Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%)
ACME UNITED CORPORATION
CGMP Deviations
Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida
New Life Pharma LLC
Lack of Assurance of Sterility
Wipes Plus, Hand Sanitizing Alcohol Free BZK Wipes (Benzalkonium Ch…
ACME UNITED CORPORATION
CGMP Deviations
First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.1…
ACME UNITED CORPORATION
CGMP Deviations
FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%
HTO Nevada Inc. dba Kirkman
Stability Data Does Not Support Expiry Date.
MAXIMUM, ZONE 2, 4% Lidocaine Cream
HTO Nevada Inc. dba Kirkman
Stability Data Does Not Support Expiry Date.