Class II · Moderate risk
Maximum Strength Zephrex-D
Microbial Contamination of Non-Sterile Products
FDA Drug Recalls
893 recalls · Class II, newest first
Class II · Moderate risk
Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine
GMP Deviations: inadequate manufacturing control processes
Class II · Moderate risk
Extra Strength Naturally HL Liquid Hemorrhoid Relief Gel
GMP Deviations: inadequate manufacturing control processes
Class II · Moderate risk
Extra Strength Naturally HL Hemorrhoid Numbing Spray with Lidocaine
GMP Deviations: inadequate manufacturing control processes
Class II · Moderate risk
Extra Strength PreTAT by TAT BALM Gel
GMP Deviations: inadequate manufacturing control processes
Class II · Moderate risk
Extra Strength Naturally HL Bed Sore Relief Cream with Added Lidocaine
GMP Deviations: inadequate manufacturing control processes
Class II · Moderate risk
ePHEDrine Sulfate In 0.9% Sodium Chloride
Subpotent Drug
Class II · Moderate risk
Estriol
cGMP Deviations: lack of quality assurance at the API manufacturer.
Class II · Moderate risk
Dutasteride and Tamsulosin HCl Capsules
Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
Class II · Moderate risk
Paroxetine Tablets
Presence of Foreign Tablets/Capsules.
Class II · Moderate risk
Succinylcholine 20 MG/ML INJ
Labeling: Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on the labeling of the outer poly bag
Class II · Moderate risk
Zoloft (sertraline HCl)
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Class II · Moderate risk
ROCuronium Bromide 10 mg per mL
Lack Of Assurance Of Sterility.
Class II · Moderate risk
Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride 50 mL Bag
Lack Of Assurance Of Sterility.
Class II · Moderate risk
PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL…
Lack Of Assurance Of Sterility.
Class II · Moderate risk
oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag
Lack Of Assurance Of Sterility.
Class II · Moderate risk
morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total…
Lack Of Assurance Of Sterility.
Class II · Moderate risk
fentaNYL as citrate 2 mcg / mL
Lack Of Assurance Of Sterility.
Class II · Moderate risk
fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125%
Lack Of Assurance Of Sterility.
Class II · Moderate risk
HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9% Sodium Chloride 50 mL
Lack Of Assurance Of Sterility.
Class II · Moderate risk
HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill…
Lack Of Assurance Of Sterility.
Class II · Moderate risk
SUCcinylcholine 20 mg per mL
Lack Of Assurance Of Sterility.
Class II · Moderate risk
Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL
Superpotent drug: out of specification result for potency
Class II · Moderate risk
Levetiracetam Oral Solution
Presence of foreign substance (screw)
Class II · Moderate risk
Norepinephrine Bitartrate16 mg added to 0.9% Sodium Chloride 250 mL bag
Lack of Assurance of Sterility.