CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.
Class IIReported terminated
Distribution: Nationwide in the USA and Puerto Rico
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
Presence of foreign substance
Presence of Foreign Substance
These examples come from this result page and are not a ranking of every recall reason.
Checking SUN PHARMACEUTICAL INDUSTRIES INC
Is there a recall on sun pharmaceutical industries inc right now?
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