Pramipexole Dihydrochloride Tablets Recalled for GMP Deviations and Cross-Contamination Risk
American Health Packaging is recalling Pramipexole Dihydrochloride Tablets due to cleaning procedure failures that may have caused cross-contamination.
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 2/5 (Moderate).
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, and the source text describes a theoretical risk of cross-contamination due to cleaning failures without reporting any specific illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
American Health Packaging is recalling Pramipexole Dihydrochloride Tablets, 0.125 mg, 30 Tablets (6 tablets per blister card), Rx Only. The recall involves 3,015 cartons distributed nationwide in the United States. The affected products are identified by Lot 179049 (exp 12/31/2019) and Lot 182571 (exp 8/31/2020), with NDC Blister Card 68084-793-95 and NDC Carton 68084-793-25.
The recall was initiated due to Good Manufacturing Practice (GMP) deviations, specifically a cleaning procedure failure that created a risk of possible cross-contamination of the product. The FDA has classified this recall as Class II, indicating a situation where 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 check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the pharmacy or distributor for replacement or refund. Patients should consult their healthcare provider regarding alternative treatment options if they are currently using the recalled medication.
The recalled product
- Product
- Pramipexole Dihydrochloride Tablets, 0.125 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-793-95; NDC Carton: 68084-793-25
- Manufacturer
- American Health Packaging
- Category
- Drug — Prescription Medication
- Affected units
- 3,015
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 (5)
- Lot
- expiry: Lot 179049
- exp 12/31/2019
- Lot 182571
- exp 8/31/2020
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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