The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1434-2019·Announced 2019-07-03

American Health Packaging Recalls Pramipexole Dihydrochloride Tablets Due to GMP Deviations

American Health Packaging is recalling Pramipexole Dihydrochloride Tablets due to GMP deviations and possible cross-contamination from cleaning failures.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class II, which corresponds to a severity score of 4 (Severe) per the rubric, as it may cause temporary or medically reversible adverse health consequences.

Plain-English summary

American Health Packaging is recalling Pramipexole Dihydrochloride Tablets, 1.0 mg, 30 Tablets (6 tablets per blister card), Rx Only. The recall involves 6,643 cartons distributed nationwide in the United States. The affected lots are 176179, 176616, 178562, 179947, 182048, 183136, and 184217, with expiration dates ranging from May 31, 2019, to August 31, 2020.

The recall was initiated due to Good Manufacturing Practice (GMP) deviations and the possibility of cross-contamination of the product resulting from a cleaning procedure failure. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers and healthcare providers should stop using the affected lots of Pramipexole Dihydrochloride Tablets and contact their healthcare provider for guidance on alternative treatment options. The recalling firm, American Health Packaging, is responsible for managing the recall and providing further information to affected parties.

The recalled product

Product
Pramipexole Dihydrochloride Tablets, 1.0 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-982-95; NDC Carton: 68084-982-25
Manufacturer
American Health Packaging
Category
Drug — Prescription Medication
Hazard
Affected units
6,643

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

  • Lot
  • expiry: Lot 176179
  • exp 05/31/2019
  • Lot 176616
  • exp 07/31/2019
  • Lot 178562
  • exp 09/30/2019
  • Lot 179947
  • exp 12/31/2019
  • Lot 182048
  • exp 04/30/2020
  • Lot 183136
  • exp 06/30/2020
  • Lot 184217
  • exp 08/31/2020

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by American Health Packaging under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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