Is Aripiprazole 10 mg per half-tab (1/2 Abilify 20 mg tab) per blister, Rx only, -Otsuka-, Pkg By: Safecor Health, Woburn, MA 01801, barcode 5914801050 recalled?

Medium RiskFDA Drug

Safecor Health, LLC: Marketed Without An Approved NDA/ANDA: Split tabs distributed as an unapproved new drug.; Marketed Without An Approved NDA/ANDA: Split tabs distributed as an unapproved new drug.

Agency Publication Date: July 8, 2011

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 58366

Status: Resolved

Manufacturer: Safecor Health, LLC

Manufactured In: United States

Units Affected: 54 products (651 blisters; 99 blisters; 233 blisters; 537 blisters; 591 blisters; 990 blisters; 1698 blisters; 58 blisters; 1,348 blisters; 3,501 blisters; 22 blisters; 118 blisters; 599 blisters; 4135 blisters; 796 blisters; 425 blisters; 59 blisters; 199 blisters; 186 blisters; 537 blisters; 398 blisters; 199 blisters; 1986 blisters; 199 blisters; 199 blisters; 295 blisters; 199 blisters; 197 blisters; 596 blisters; 197 blisters; 178 blisters; 238 blisters; 49 blisters; 497 blisters; 190 blisters; 597 blisters; 47,491 blisters; 652 blisters; 5,907 blisters; 199 blisters; 198 blisters; 99 blisters; 258 blisters; 885 blisters; 199 blisters; 1,100 blisters; 694 blisters; 198 blisters; 992 blisters; 991 blisters; 5977 blisters; 199 blisters; 496 blisters; 295 blisters)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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