Class II · Moderate risk Terminated
Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS
Reason Lack of Assurance of Sterility
FDA Drug Recalls
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Class II · Moderate risk Terminated
Sodium Phenylbutyrate Powder
Reason Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
Class II · Moderate risk Terminated
Cleaning Solutions Foaming Hand Sanitizer
Reason CGMP Deviations: Use of this product may cause possible infection/ irritation of the skin and/or soft tissues.
Class II · Moderate risk Terminated
ceFAZolin 3 G in 0.9% Sodium Chloride
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
ceFAZolin
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Morphine Sulfate Injection
Reason Defective container: Cracked vials leading to lack of sterility assurance
Class II · Moderate risk Terminated
GlipiZIDE Extended-Release Tablets
Reason Failed Dissolution Specifications: results were above specification.
Class II · Moderate risk Terminated
Valproic Acid Oral Solution
Reason CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk Terminated
Zonisamide 100 mg Capsules
Reason CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Class III · Low risk Terminated
Candesartan Cilexetil Tablets
Reason Failed Impurities/Degradation Specifications; out of specification for Related Compound
Class II · Moderate risk Terminated
Rocuronium Bromide Injection 50mg/5 mL
Reason Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
Class II · Moderate risk Terminated
Metoprolol Tartrate Tablets USP 100 mg
Reason Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
Class II · Moderate risk Terminated
Kroger 70% Isopropyl Alcohol First Aid Antiseptic 32 FL OZ
Reason Labeling: Label Mix-Up.The recall has been initiated after receiving one complaint about incorrect labeling.The primary label on the front and back label on some of the bottles have 70% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces
Class I · High risk Terminated
Ruzurgi
Reason Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.
Class II · Moderate risk Terminated
TheraTears Extra
Reason Lack of Assurance of Sterility
Class I · High risk Terminated
AMINOSYN II 15% An Amino Acid Injection
Reason Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
Class III · Low risk Terminated
Glycopyrrolate Injection
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials…
Reason Subpotent Drug
Class III · Low risk Terminated
Daytime Severe Cold & Flu Relief 8 Pre-Measured Vials 0.51 FL OZ
Reason Subpotent Drug
Class III · Low risk Terminated
Hydroquinone
Reason Subpotency: one product for active ingredient assay and another one for preservative assay
Class III · Low risk Terminated
Sodium Sulfacetamide
Reason Subpotency: one product for active ingredient assay and another one for preservative assay
Class I · High risk Terminated
Avicel RC-591 NF
Reason Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC).
Class II · Moderate risk Terminated
Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC…
Reason CGMP Deviations