Is Oxycodone and Acetaminophen Capsules, USP, CII, 5 mg/500 mg, Rx only, 100 count bottles , Manufactured by Amide Pharmaceutical Inc., Little Falls, NJ/Actavis Totowa LLC, Totowa, NJ recalled?

cGMP Deviations Distribution: Nationwide distribution to wholesale distribution centers.

Medium RiskFDA Drug

Actavis Totowa LLC: cGMP Deviations

Agency Publication Date: November 23, 2008

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 49023

Status: Resolved

Manufacturer: Actavis Totowa LLC

Manufactured In: United States

Units Affected: 50 products (10 lots; 19, 169 bottles; 1 lot, 552 bottles; 11 lots; 164,597 bottles of 100 count; 47,820 bottles of 250 count.; 22 lots, 28301 bottles of 30 count, 8029 bottles of 100 count.; 15 lots; 264 bottles of 100, 19130 bottles of 1000; 16 lots; 75143 bottles; 11 lots; 24896 bottles; 11 lots; 78649 bottles (Amide/Actavis), 19,526 bottles Sanofi; 5 lots; 17917 bottles (Amide), 4919 bottles Sanofi; 12 lots; 118596 bottles; 4 lots; 3054 bottles; 9 lots; 8190 bottles; 7 lots, 6834 bottles; 10 lots; 7030 bottles; 5 lots Amide/Actavis, 36862 bottles; 1 lot Sanofi Aventis. 7531 bottles; 87 lots 100 count, 1,298,977 bottles; 2 lots 10x10 blister pack, 2592 cartons.; 128 lots 100 count, 2199977 bottles; 2 lots 10 x 10 blister pack, 1764 boxes.; 11 lots; 175,817 bottles; 6 lots Amide/Actavis, 14,326 bottles; 4 lots Major, 2400 bottles; 23 lots Actavis/Amide, 29730 bottles; 4 lots Major, 4080 bottles; 26 lots Amide/Actavis, 46,388 bottles; 9 lots Major, 2555 bottles; 5 lots, 2892 bottles; 16 lots; 64505 bottles 150 count, 1597 bottles 500 count.; 49 lots; 135135 bottles 150 count, 15472 bottles 500 count.; 9 lots,87079 bottles; Actavis/Amide - 12 lots, 43404 bottles; Cobalt, 2 lots, 7916 bottles; 11 lots , 22,200 bottles; 12 lots; 158-81 bottles 30 count, 22048 bottles 90 count.; 48 lots; 81,3567 bottles 30 count; 146,595 bottles 90 count; 22 lots,, 300017 bottles 30 count; 50794 bottles 90 count.; 3 lots, 42741 bottles; 15 lots, 208,894 bottles; 36 lots; 211,341 bottles; 3 lots, 7235 bottles; 2 lots, 8560 bottles; 2 lots, 16128 bottles; 18 lots; 36839 bottles; 25 lots, 76803 bottles; 24 lots, 85397 bottles; 4 lots; 14544 100 count bottles, 1800 500 count bottles; 6 lots; 12240 bottles 100 count, 3240 bottles 500 count; 11 lots; 18564 bottles; 16 lots, 27255 bottles; 2 lots, 864 bottles; 12 lots; 168373 bottles Amide/Actavis; 4 lots, 59399 bottles Pliva; 12 lots; 59399 bottles 100 count, 14832 bottles 1000 count; 20 lots; 20391 bottles 100 count; 8132 bottles 1000 count; 31 lots; 21872 bottles 100 count, 18322 bottles 1000 count; 14 lots; 10154 bottles 100 count, 3852 bottles 1000 count; 23 lots, 10407 bottles)

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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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