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Parkinson Disease Drug Pulled


July 05, 2019

Cross-contamination concerns have prompted American Health Packaging to issue a voluntary recall for more than 35,000 cartons of pramipexole, according to the July 3, 2019, US Food and Drug Administration (FDA) Enforcement Report. The potential for cross-contamination occurred because of a cleaning procedure failure. 

The following products, which were distributed throughout the United States, are affected by the recall: 

  • pramipexole dihydrochloride, 0.125 mg, 30 tablets, 6 tablets per blister card (blister card NDC 68084-793-95; carton NDC 68084-793-25), from lots 179049 (Exp. 12/31/19) and 182571 (Exp. 8/31/20); 
  • pramipexole dihydrochloride, 0.25 mg, 100 tablets, 10 x 10 (blister card NDC 68084-440-11; carton NDC 68084-440-01), from lots 172669 (Exp. 5/31/19), 175872 and 177086 (Exp. 9/30/19), 179047 (Exp. 12/31/19), and 182584 (Exp. 7/31/20); 
  • pramipexole dihydrochloride, 0.5 mg, 30 tablets, 6 tablets per blister card (blister card NDC 68084-974-95; carton NDC 68084-974-25), from lots 175820 and 176569 (Exp. 9/30/19), 177866, 179627A, and 179627B (Exp. 12/31/19), and 181627 (Exp. 6/30/20); and 
  • pramipexole dihydrochloride, 1.0 mg, 30 tablets, 6 tablets per blister card (blister card NDC 68084-982-95; carton NDC 68084-982-25), from lots 176179 (Exp. 5/31/19), 176616 (Exp. 7/31/19), 178562 (Exp. 9/30/19), 179947 (Exp. 12/31/19), 182048 (Exp. 4/30/20), 183136 (Exp. 6/30/20), and 184217 (Exp. 8/31/20). 

American Health Packaging initiated the recall May 13, 2019. On June 27, 2019, the FDA designated it Class II. Under Class II recalls, use of the product could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm. 

Pramipexole is a prescription dopamine agonist used to treat patients with Parkinson disease and restless legs syndrome. 

Jolynn Tumolo

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