Is ISOSORBIDE MONONITRATE 10mg TABLET, 250 count bags (NDC 61392-912-25) & 30 count boxes (NDC 61392-912-30), Rx only, Pkg by Heartland Repack Services, Toledo, OH recalled?

Recall reasons: • Mispacked; possibility of a product package mix-up. • There is the possibility of a product package mix-up. Distribution: The recalled products were distributed to pharmacy/ customers in the following locations nationwide: TX, NV, MD, FL, NJ, OH, RI, WI, IL, GA, AR, CA, WA, MS, KY, AZ, LA, IN, PA, OR, TN, VA, WV, MO, ID, MA, NM, NY, MT, KS, NH, SC, VT, IA, NC, CO, ME, MN, NE, NV, SD, MI, AL, UT, and CT.

Medium RiskFDA Drug

Heartland Repack Services LLC: Mispacked; possibility of a product package mix-up.; There is the possibility of a product package mix-up.

Agency Publication Date: November 3, 2006

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 36014

Status: Resolved

Manufacturer: Heartland Repack Services LLC

Manufactured In: United States

Units Affected: 87 products (87/250 count bags & 2184/30 count boxes; 40/250 count bags & 2042/30 count boxes; 97/250 count bags & 3413/30 count boxes; 304/250 count bags & 25,522/30 count boxes; 149/250 count bags & 13,364/30 count boxes; 276/250 count bags, 1593/30 count boxes & 20/60 count boxes; 3822/250 count bags & 140,978/30 count boxes; 14/60 count boxes; 163/250 count bags & 3735/30 count boxes; 143/250 count bags & 3788/30 count boxes; 160/250 count bags & 3514/30 count boxes; 1259/30 count boxes; 41/250 count bags & 2092/30 count boxes; 36/250 count bags & 1072/30 count boxes; 2973/30 count boxes; 108/30 count boxes; 128/250 count bags & 3917/30 count boxes; 278/250 count bags, 4533/30 count boxes & 181/60 count boxes; 89/250 count bags & 2937/30 count boxes; 62/250 count bags & 2691/30 count boxes; 230/250 count bags & 1822/30 count boxes; 372/250 count bags & 3823/30 count boxes; 199/250 count bags & 1131/30 count boxes; 63/250 count bags & 2215/30 count boxes; 31/250 count bags & 1757/30 count boxes; 84/250 count bags & 1638/30 count boxes; 328/250 count bags, 3728/30 count boxes & 91/90 count boxes; 169/250 count bags, 4273/30 count boxes & 604/60 count boxes; 1692/250 count bags & 46,245/30 count boxes; 91/250 count bags, 799/30 count boxes & 725/60 count boxes; 536/250 count bags & 14,921/30 count boxes; 468/250 count bags & 9838/30 count boxes; 1223/30 count boxes; 19/250 count bags & 194/30 count boxes; 98/250 count bags & 2000/30 count boxes; 270/250 count bags, 3076/30 count boxes & 118/60 count boxes; 36/250 count bags & 1336/30 count boxes; 100/250 count bags, 1474/30 count boxes & 20/60 count boxes; 298/60 count boxes & 35/90 count boxes; 137/250 count bags & 2139/30 count boxes; 61/250 count bags, 827/30 count boxes & 290/60 count boxes; 132/250 count bags, 3322/30 count boxes & 367/60 count boxes; 504/30 count boxes & 714/60 count boxes; 256/250 count bags, 2625/30 count boxes & 3/60 count boxes; 1211/250 count bags, 13,325/30 count boxes & 12/60 count boxes; 54/250 count bags & 2605/30 count boxes; 221/250 count bags, 2515/30 count boxes , 150/60 count boxes & 50/90 count boxes; 112/250 count bags & 1080/30 count boxes; 23/250 count bags & 435/30 count boxes; 59/250 count bags & 2165/30 count boxes; 389/250 count bags & 9510/30 count boxes; 66/250 count bags & 1265/30 count boxes; 59/250 count bags, 998/30 count boxes & 35/60 count boxes; 214/250 count bags & 4805/30 count boxes; 254/250 count bags, 5672/30 count boxes & 222/60 count boxes; 269/250 count bags & 6517/30 count boxes; 64/250 count bags & 1731/30 count boxes; 40/250 count bags & 1235/30 count boxes; 67/250 count bags & 1059/30 count boxes; 109/250 count bags, 2547/30 count boxes & 19/60 count boxes; 47/250 count bags & 2253/30 count boxes; 71/250 count bags & 2946/30 count boxes; 82/250 count bags & 1504/30 count boxes; 8807/30 count boxes; 2729/30 count boxes; 33/250 count bags; 164/250 count bags & 3106/30 count boxes; 13/250 count bags & 131/30 count boxes; 8/250 count bags & 92/30 count boxes; 102/250 count bags & 4410/30 count boxes; 101/250 count bags & 3272/30 count boxes; 77/250 count bags & 2818/30 count boxes; 1552/30 count boxes; 291/250 count bags, 889/30 count boxes & 2424/60 count boxes; 386/250 count bags & 14,604/30 count boxes; 162/250 count bags & 7844/30 count boxes; 162/250 count bags & 7844/30 count boxes; 124/250 count bags & 4511/30 count boxes; 57/250 count bags; 119/250 count bags & 1449/30 count boxes; 97/250 count bags & 1959/30 count boxes; 195/30 count boxes; 109/250 count bags; 44/250 count bags & 793/30 count boxes; 33/250 count bags, 2859/30 count boxes & 215/60 count boxes; 237/250 count bags, 4174/30 count box & 239/60 count boxes; 14/250 count bags & 815/30 count boxes)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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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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