Pramipexole Dihydrochloride Tablets Recalled for GMP Deviations and Cross-Contamination Risk
American Health Packaging is recalling Pramipexole Dihydrochloride Tablets due to GMP deviations and a cleaning procedure failure that may have caused cross-contamination.
What this means for you
Illness, injury, or structural failure has been reported. 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. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential contamination or GMP deviations that could lead to adverse health consequences.
Plain-English summary
American Health Packaging is recalling Pramipexole Dihydrochloride Tablets, 0.5 mg, 30 Tablets (6 tablets per blister card), Rx Only. The recall involves 8,777 cartons distributed nationwide in the United States. The specific lots affected are 175820 and 176569 (exp 09/30/2019), 177866, 179627A, and 179627B (exp 12/31/2019), and 181627 (exp 06/30/2020).
The recall was initiated due to Good Manufacturing Practice (GMP) deviations and a cleaning procedure failure that resulted in the possible cross-contamination of the product. 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.
Patients and healthcare providers should discontinue use of the affected lots and contact their pharmacist or prescriber for guidance on alternative treatment options. Consumers should check their medication packaging for the specific lot numbers and expiration dates listed above to determine if their supply is affected.
The recalled product
- Product
- 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
- Manufacturer
- American Health Packaging
- Category
- Drug — Prescription Medication
- Affected units
- 8,777
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 (10)
- Lot
- expiry: Lots 175820
- 176569
- exp 09/30/2019
- Lots 177866
- 179627A
- 179627B
- exp 12/31/2019
- Lot 181627
- exp 06/30/2020
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.
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