Class II · Moderate risk
Amphotericin B Liposome for Injection
Out of specification for assay
Wrong potency or content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk.
992 FDA drug recalls with this cause, newest first.
These recalls cover sub-potent or super-potent products, or a failed content-uniformity test - meaning some pills in the same batch held noticeably different amounts of active ingredient than others. Either way it is a direct dosing risk: too little to work, or too much and harmful. Thyroid hormones and compounded injectables are the classic examples, because their dose window is narrow.
Class III · Low risk
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free
Out of specification for assay
Class II · Moderate risk
Class I · High risk
Sapropterin Dihydrochloride Powder for Oral Solution 100mg
Sub-potent Drug; powder discoloration associated with decreased potency
Class I · High risk
Javygtor (sapropterin dihydrochloride)
Sub-potent Drug; powder discoloration associated with decreased potency
Class II · Moderate risk
Isotretinoin Capsules
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Class I · High risk
Vancomycin Hydrochloride for Oral Solution
Superpotent Drug: Due to overfilling of drug powder
Class II · Moderate risk
Rifampin Capsules USP
Subpotent Drug
Class II · Moderate risk
Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1
Subpotent Drug: Out of specification for assay
Class II · Moderate risk
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection
Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
Class II · Moderate risk
Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride
Subpotent Drug
Class II · Moderate risk
Vasostrict
Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
Class II · Moderate risk
Rifampin Capsules USP 300mg
Subpotent Drug and Failed Impurities/Degradation Specifications
Class II · Moderate risk
Rifampin Capsules USP 150mg
Subpotent Drug and Failed Impurities/Degradation Specifications
Class I · High risk
VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I · High risk
VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I · High risk
PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I · High risk
PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I · High risk
FentaNYL citrate PF
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I · High risk
FentaNYL citrate PF
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class III · Low risk
Benzonatate Capsules
Superpotent drug: Assay results were slightly above specification at the time zero point.
Class I · High risk
Phenytoin Oral Suspension
Failed Content Uniformity Specifications
Class II · Moderate risk
Equate Hand Sanitizer
Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
Class II · Moderate risk
DOP Instant Hand Sanitizer
Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
Class II · Moderate risk
DOP Instant Hand Sanitizer
Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
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