Pramipexole Dihydrochloride Tablets Recalled for GMP Deviations and Cross-Contamination Risk
American Health Packaging is recalling Pramipexole Dihydrochloride Tablets due to GMP deviations and possible cross-contamination from cleaning failures.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The source cites GMP deviations and possible cross-contamination without reporting specific illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
American Health Packaging is recalling Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10), Rx Only. The recall involves 16,698 cartons distributed nationwide in the United States. The specific NDC numbers are 68084-440-11 for the blister card and 68084-440-01 for the carton.
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 affected lots include Lot 172669 (exp 05/31/2019), Lots 175872 and 177086 (exp 09/30/2019), Lot 179047 (exp 12/31/2019), and Lot 182584 (exp 07/31/2020).
Patients and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the pharmacy or distributor for replacement or refund. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-440-11; NDC Carton: 68084-440-01
- Manufacturer
- American Health Packaging
- Category
- Drug — Prescription Medication
- Affected units
- 16,698
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: Lot 172669
- exp 05/31/2019
- Lots 175872
- 177086
- exp 09/30/2019
- Lot 179047
- exp 12/31/2019
- Lot 182584
- exp 07/31/2020
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.
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