Drug recalls
500 recallsESTRADIOL, 12.5 mg, 1 Sterile Pellet
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Presence of Foreign substance - potential presence of metal particulate matter
UDENYCA, pegfilgrastim-cbqv injection
McKesson
Temperature Abuse.
acyclovir sodium, 200 mg, 200mg added to 100 mL
Fresenius Kabi Compounding, LLC
Lack of Assurance of Sterility
Testosterone, 18.0 mg, 1 Sterile Pellet
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Presence of Foreign substance - potential presence of metal particulate matter
ESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Presence of Foreign substance - potential presence of metal particulate matter
Testosterone, 50.0 mg, 1 Sterile Pellet
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Presence of Foreign substance - potential presence of metal particulate matter
Testosterone, 100 mg, 1 Sterile Pellet
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Presence of Foreign substance - potential presence of metal particulate matter
Pro Numb Tattoo Numbing Spray, 5% Lidocaine
Pro Numb Tattoo Numbing Spray LLC
cGMP deviations
thiamine HCl, 500 mg, 500 mg added to 100 mL
Fresenius Kabi Compounding, LLC
Lack of Assurance of Sterility
ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodiu…
Fresenius Kabi Compounding, LLC
Lack of Assurance of Sterility
Oxycodone Hydrochloride Tablets, USP (CII), 5 mg
Amerisource Health Services LLC
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling…
Testosterone, 200 mg, 1 Sterile Pellet
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Presence of Foreign substance - potential presence of metal particulate matter
Testosterone, 25.0 mg, 1 Sterile Pellet
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Presence of Foreign substance - potential presence of metal particulate matter
ESTRADIOL, 25 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Presence of Foreign substance - potential presence of metal particulate matter
vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL
Fresenius Kabi Compounding, LLC
Lack of Assurance of Sterility
Testosterone, 87.5 mg, 1 Sterile Pellet
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Presence of Foreign substance - potential presence of metal particulate matter
ESTRADIOL, 10 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Presence of Foreign substance - potential presence of metal particulate matter
Testosterone 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Presence of Foreign substance - potential presence of metal particulate matter
vancomycin HCl, 2 grams, 2 grams added to 500 mL
Fresenius Kabi Compounding, LLC
Lack of Assurance of Sterility
Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only
SUN PHARMACEUTICAL INDUSTRIES INC
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] resul…
Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP
Unichem Pharmaceuticals USA Inc.
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10
Green Lumber Holdings, LLC
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil
Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only
Granules Pharmaceuticals Inc.
Presence of Foreign Tablets/Capsules
Rheumacare capsules, 30 count bottle
HANDELNINE GLOBAL LLC
CGMP Deviations: product found to contain lead.
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle
Baxter Healthcare Corporation
Presence of particulate matter: plastic particles from the bottle rim were observed floating into…
INON ACE Antacid tablets (magnesium aluminosilicate
Sato Pharmaceutical Co., Ltd
Failed Disintegration Specifications: above the time expected.
methylprednisolone tablets, USP Dosepak, 4 mg
Greenstone Llc
Labeling: Not Elsewhere Classified.
Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only
NOVADOZ PHARMACEUTICALS LLC
Failed Impurities/Degradation Specifications
parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash
Haleon US Holdings LLC
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and ex…
Furosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only
Graviti Pharmaceuticals Private Limited
Presence of Foreign Substance