AHP Nifedipine Capsules Recalled for Presence of Foreign Tablets
Amerisource Health Services is recalling AHP Nifedipine Capsules, 10mg, due to the presence of foreign tablets or capsules in the packaging.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 FDA classified this as a Class III recall, which indicates a low probability of adverse health consequences. The hazard involves foreign objects in packaging, which is a quality control issue rather than a direct toxicological or biological threat.
Plain-English summary
Amerisource Health Services is recalling AHP Nifedipine Capsules, 10mg USP, 100 count cartons and individual blisters. The recall was initiated because of the presence of foreign tablets or capsules in the product.
The affected product was manufactured by Actavis Elizabeth, LLC and packaged and distributed by American Health Packaging in Columbus, Ohio. The recall involves 5,283 cartons, totaling 528,300 capsules, distributed in the United States. Specific lots affected include Lot #155404 (Exp 01/18) and Lots #161139, #163060, #164054, and #164809 (Exp 03/18).
Consumers and healthcare providers should check their inventory for these specific NDCs and lot numbers. If the product is found, it should be returned to the pharmacy or distributor for a refund or replacement. Patients should consult their healthcare provider for alternative medication if necessary.
The recalled product
- Product
- AHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01); Individual Blister (NDC: 68084-022-11), Rx Only, Manufactured by: Actavis Elizabeth, LLC, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217
- Manufacturer
- Amerisource Health Services
- Category
- Drug — Prescription Medication
- Hazard
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 (6)
- Lot #155404
- Exp 01/18 Lot #161139
- 163060
- 164054
- 164809
- Exp 03/18
Distribution
Distribution scope not specified by the agency.
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