Nitrofurantoin Capsules Recalled for Potential Cross-Contamination with Unrelated Ingredients
American Health Packaging is recalling specific lots of Nitrofurantoin Capsules due to potential cross-contamination with unrelated active ingredients.
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 III, which is defined as unlikely to cause adverse health consequences. The hazard involves potential cross-contamination with unrelated ingredients, which fits the criteria for a moderate severity recall involving low-risk contamination or voluntary precautionary measures.
Plain-English summary
American Health Packaging is recalling 4,508 blister packs of Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Unit Dose Blisters. The affected product is identified by NDC 68084-446-01 (Individual Dose NDC: 68064-446-11) and includes lots 180310 and 180612 with an expiration date of 03/31/20. The product was distributed nationwide in the United States.
This sub-recall is being initiated in support of a manufacturer recall by Sandoz dated November 1, 2018. Sandoz stated that the lots are being recalled due to the potential presence of unrelated ingredients, specifically traces of active ingredients from Benazepril, Haloperidol, and Perphenazine, which were identified through a manufacturing investigation.
Consumers and healthcare providers should check their inventory for the specific lot numbers and NDC codes listed above. If the product is found, it should be removed from use and returned to the supplier or disposed of according to local regulations.
The recalled product
- Product
- Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Unit Dose Blisters, Rx only, Amerisource Health Services DBA American Health Packaging, 2550-A John Glenn Avenue Columbus, OH 43217, NDC 68084-446-01 (Individual Dose NDC: 68064-446-11)
- Manufacturer
- AMERICAN HEALTH PACKAGING
- Category
- Drug — Antibiotic
- Affected units
- 4,508
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 (3)
- Lot#: 180310
- 180612
- Exp 03/31/20
Distribution
Distributed nationwide across the United States.
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