Class II · Moderate risk
Lansoprazole Delayed-release Capsules
Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets.
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
Terazosin Hydrochloride Capsules
Presence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in one bottle.
Class II · Moderate risk
Irinotecan Hydrochloride Injection
Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
Class II · Moderate risk
Medi-bolic Booster Injectable
CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures.
Class II · Moderate risk
Mercuroclear Antiseptic Anesthetic First Aid Helps prevent…
Microbial Contamination of Non-Sterile Product(s): The product has the potential to be contaminated with Bulkholderia gladioli.
Class II · Moderate risk
Carvedilol Tablets
Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.
Class II · Moderate risk
Furosemide Injection USP
Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Lack of Assurance of Sterility: There is the potential for solution to leak from the administrative port to the fill tube seal.
Class II · Moderate risk
Belladonna Alkaloids
Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.
Class II · Moderate risk
Hillyard
Microbial Contamination of Non-Sterile Products: The product may be contaminated with bacteria.
Class II · Moderate risk
12-Hour Sinus
Microbial Contamination of a Non-Sterile Products: 12-Hour Sinus Nasal Spray under various labeling are being recalled due to microbial contamination identified during testing.
Class II · Moderate risk
Taztia XT
Failed Dissolution Specification: Out of a specification result occurred during the 3-month stability testing. Dissolution result at the 4-hour time point was 41% (specification: 20-40%).
Class II · Moderate risk
EXPAREL (bupivacaine liposome injectable suspension)
Subpotent; bupivacaine
Class II · Moderate risk
Prednisone tablets
Presence of Foreign Substance(s); Perrigo has been notified of a recall by the manufacturer of this product, West-Ward Pharmaceuticals. This is a sub-recall due to tablets contaminated with trace amounts of food-grade lubricant, as well as stainless steel inclusions
Class II · Moderate risk
Temodar (temozolomide)
Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected during stability monitoring.
Class II · Moderate risk
Carisoprodol Tablets
Presence of Foreign Substance: Uncharacteristic blacks spots on tablets.
Class II · Moderate risk
Propylthiouracil Tablets
Presence of Foreign Substance: Uncharacteristic spots identified as steel corrosion, degraded tablet material and hydrocarbon oil with trace amounts of iron were found in tablets.
Class II · Moderate risk
Lisinopril Tablets
Presence of Foreign Substance: Uncharacteristic black spots identified as a food grade lubricant with trace amounts of foreign particulates and stainless steel inclusions have been found in the tablets.
Class II · Moderate risk
Oxygen
Failed impurities/degradation specifications: Purity readings for oxygen were out of specification.
Class II · Moderate risk
Copaxone (glatiramer acetate injection)
Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints related to a visible presence of medical grade silicone oil essential to the functionality of the syringe and plunger stopper system.
Class II · Moderate risk
PredniSONE Tablets
Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the tablets.
Class II · Moderate risk
PredniSONE Tablets
Presence of Foreign Substance: A complaint was received for black specks identified as stainless steel inclusions and cellulose with trace amounts of aluminum and iron-rich inclusions.
Class II · Moderate risk
Isoniazid Tablets 300 mg tablets USP
Failed Dissolution Specifications; 36 month stability timepoint
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 · 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.