Class II · Moderate risk
Dextroamphetamine Sulfate Extended Release Capsules
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
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.
14,535 recalls, newest first.
Class II · Moderate risk
Synthroid (Levothyroxine Sodium)
Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.
Class II · Moderate risk
VERSAPHARM Ethambutol Tablets
Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored.
Class II · Moderate risk
Lisinopril and Hydrochlorothiazide Tablets
Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets.
Class II · Moderate risk
NorthStar Arthritis Relief Cream. Net Wt. 2 oz tube
Microbial Contamination of Non-Sterile Products: Arthritis Relief Cream failed microbiological specifications.
Class II · Moderate risk
Nalbuphine HCl Injection
Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip cap were received and therefore sterility cannot be assured.
Class II · Moderate risk
Fluorouracil Topical Cream USP
Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
Class II · Moderate risk
Propranolol Hydrochloride Extended-release Capsules
Failed Dissolution Test Requirements
Class II · Moderate risk
Levothyroxine Tablets
Subpotent; 15 month stability (by mfr)
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: Visible particulate and particulate embedded in vials were observed during retain inspection.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Class II · Moderate risk
Vicks NyQuil Cold & Flu
Labeling Illegible: Portions of the product labeling in the area of the dosing directions, the warnings & other information sections is obscured.
Class II · Moderate risk
VIVITROL (naltrexone for extended-release injectable suspension)
Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.
Class II · Moderate risk
traMADOL Hydrochloride Tablets
Adulterated Presence of Foreign Tablets: A customer complaint was received that a bottle of Tramadol HCl Tablets USP 50 mg contained some tablets of Metoprolol Tartrate Tablets USP, 50 mg.
Class II · Moderate risk
Pradaxa (dabigatran etexilate)
Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product
Class II · Moderate risk
ABILIFY (aripiprazole)
CGMP Deviations: A drum of Abilify 30 mg Tablets rejected during the compression stage was not segregated from the other portion of the lot and was inadvertently shipped, packaged and distributed.
Class II · Moderate risk
All Non-Sterile Products manufactured by Ameridose LLC
GMP deficiencies
Class II · Moderate risk
All Sterile Products manufactured by Ameridose LLC
Lack of assurance of sterility
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent; 15 month stability
Class II · Moderate risk
Epinephrine Injection USP
Presence of Particulates; may contain glass particles
Class II · Moderate risk
HEXTEND 6% Hetastarch in Lactated Electrolyte Injection
Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag.
Class II · Moderate risk
Necon 1/35-28
Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).
Class II · Moderate risk
Necon 10/11
Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).