Class II · Moderate risk
B-Complex Without B12 W/Pres
Lack of Assurance of Sterility
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
Class II · Moderate risk
B-Complex Without B12
Lack of Assurance of Sterility
Class II · Moderate risk
B-COMPLEX (Lieberman)
Lack of Assurance of Sterility
Class II · Moderate risk
B-Complex #3 W/Pres
Lack of Assurance of Sterility
Class II · Moderate risk
B-Complex #3
Lack of Assurance of Sterility
Class II · Moderate risk
aloe SPORT liniment TOPICAL ANALGESIC 8 fl oz. tube
CGMP Deviations
Class II · Moderate risk
1% Clotrimazol cream
CGMP Deviations
Class II · Moderate risk
VERMOX Tablets 500 mg
CGMP Deviations
Class II · Moderate risk
VERMOX Tablets 100 mg
CGMP Deviations
Class II · Moderate risk
tabcin NOCHE
CGMP Deviations
Class II · Moderate risk
tabcin ACTIVE M.R. Capsules
CGMP Deviations
Class II · Moderate risk
Tazorac (tazarotene)
Failed Content Uniformity Specifications.
Class II · Moderate risk
Tazorac (tazarotene)
Failed Content Uniformity Specifications.
Class II · Moderate risk
Coppertone SUNSCREEN LOTION
Labeling; Product Contains Undeclared API (Oxybenzone)
Class II · Moderate risk
Bromocriptine Mesylate Capsules USP
Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (25 degree Celsius /65% RH) stability samples of two batches.
Class II · Moderate risk
Vancomycin Hydrochloride for Injection
Presence of Particulate Matter: Cardboard
Class II · Moderate risk
8 mcg/mL HYDROmorphone HCl and 0.05% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
6.66 mcg/mL Fentanyl Citrate and 0.22% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
6.66 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
5 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
5 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
5 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
5 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
5 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.