Drug recall
Acetaminophen 500 mg Caplet, 250 count bags (NDC 61392-948-25) & 30 count boxes (NDC 61392-948-30), OTC, Pkg…
FDA recall event 35963 · Class II · Heartland Repack Services LLC
Key facts
| Event ID | 35963 |
|---|---|
| Recall numbers | D-007-7, D-008-7, D-009-7, D-010-7, D-011-7, D-012-7, D-013-7, D-014-7, D-015-7, D-016-7, D-017-7, D-018-7 and 182 more |
| Recalling firm | Heartland Repack Services LLC |
| Product type | Drugs |
| Products | Acetaminophen 500 mg Caplet, 250 count bags (NDC 61392-948-25) & 30 count boxes (NDC 61392-948-30), OTC, Pkg by Heartland Repack, Toledo, OH, Acetaminophen 500mg Tablets, 250 count bags (NDC 61392-030-25), & 60 count boxes (NDC 61392-030-60), OTC, Pkg by Heartland Repack, Toledo, OH, Acetazolamide 250mg Tablet, 250 count bags (NDC 61392-176-25) & 30 count boxes (NDC 61392-176-30), Rx, Pkg by Heartland Repack, Toledo, OH, Albuterol Sulfate 2mg Tablet, 250 count bags (NDC 61392-567-25), 30 count boxes (NDC 61392-567-30), 60 count boxes (NDC 61392-567-60), & 90 count boxes (NDC 61392-567-90), Rx, Pkg by Heartland Repack…, Albuterol Sulfate 4mg Tablet, 250 count bags (NDC 61392-570-25) & 30 count boxes (NDC 61392-570-30), Rx, Pkg by Heartland Repack, Toledo, OH and 189 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Mispacked; correct labeled product may be mispacked |
| Initiation date | Jul 28, 2006 |
| Termination date | Apr 23, 2009 |
| City | Toledo |
| State | OH |
| Country | United States |
| FEI number | 1000305984 |
At a glance
- 100–999 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports