🔍 RecallPedia

Pramipexole Dihydrochloride Tablets, 0.5 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-974-95; NDC Carton: 68084-974-25

Class I - Dangerous
💊 Drugs Recalled: May 13, 2019 American Health Packaging Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot, expiry: Lots 175820, 176569, exp 09/30/2019; Lots 177866, 179627A, 179627B, exp 12/31/2019; Lot 181627, exp 06/30/2020
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
American Health Packaging
Reason for Recall:
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Pramipexole Dihydrochloride Tablets, 0.5 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-974-95; NDC Carton: 68084-974-25

Product Codes/Lot Numbers:

Lot, expiry: Lots 175820, 176569, exp 09/30/2019; Lots 177866, 179627A, 179627B, exp 12/31/2019; Lot 181627, exp 06/30/2020

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1433-2019

Related Recalls

Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10 cards per carton, Unit Dose NDC 68084-446-11, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 68084-446-01

American Health Packaging

Class I - Dangerous

Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.

May 3, 2022 Prescription Drugs Nationwide View Details →