Class II · Moderate risk
Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous…
Lack of Assurance of Sterility
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Tablets
Presence of Foreign Substance- Potential of metal contamination.
Class III · Low risk
Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer
Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'
Class I · High risk
Atovaquone Oral Suspension
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Class II · Moderate risk
NIFEdipine EXTENDED-RELEASE TABLETS
Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
Class II · Moderate risk
MIC+Methyl B12 injection Methionine Inositol…
Lack of processing controls
Class II · Moderate risk
Global Hand Sanitizer with moisturizer
CGMP Deviations: Does not meet monograph for denaturant.
Class II · Moderate risk
Global Hand Sanitizer with moisturizer
CGMP Deviations: Does not meet monograph for denaturant.
Class II · Moderate risk
Zyprexa Intramuscular
cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.
Class II · Moderate risk
Xylocaine-MPF with Epinephrine 1:200
Low out of specification results for epinephrine assay.
Class III · Low risk
LEUKINE (Sargramostim)
FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.
Class I · High risk
Limar Hand Sanitizer
Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
Class III · Low risk
Erythromycin Topical Gel
Failed Impurities/Degradation Specifications
Class III · Low risk
Erythromycin Topical Solution USP
Failed Impurities/Degradation Specifications
Class II · Moderate risk
QiYu Hand Sanitizer
Subpotent
Class I · High risk
Prairie Wolf Distillery Alcohol Antiseptic 80%
Hand sanitizer packaged in bottles that resemble beverage containers.
Class I · High risk
Topotecan Injection 4 mg/4mL
Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis where two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber.
Class III · Low risk
B-Force
Superpotent
Class II · Moderate risk
Acetaminophen 325 mg tablets
cGMP deviations: Discolored acetaminophen
Class II · Moderate risk
Solifenacin Succinate Tablets
CGMP Deviations
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk
Xolair (omalizumab)
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
Class II · Moderate risk
QiYu Hand Sanitizer Gel
Subpotent