American Health Packaging Recalls Nitrofurantoin Capsules for Dissolution Failure
American Health Packaging is recalling 1,948 cartons of Nitrofurantoin Capsules USP 100 mg because they failed dissolution specifications. The recall is nationwide.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text identifies this as an FDA Class II recall. According to the rubric, an FDA Class II recall is classified as Severe (Score 4), as it may cause temporary or medically reversible adverse health consequences.
Plain-English summary
American Health Packaging is recalling 1,948 cartons of Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg. The product is distributed nationwide in the United States. The specific lot number is 193757, with an expiration date of 1/31/2022. The NDC numbers are 68084-446-01 for the carton and 68084-446-11 for the blister card.
The recall was initiated because the product failed dissolution specifications. Dissolution tests ensure that the medication releases its active ingredient at the correct rate in the body. When these specifications are not met, the medication may not work as intended.
This is a Class II recall, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance on replacement or alternative treatment.
The recalled product
- Product
- Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton: 68084-446-01; NDC Blister Card: 68084- 446-11
- Manufacturer
- American Health Packaging
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 1,948
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 (2)
- Lot # 193757
- Exp 1/31/2022
Distribution
Distributed nationwide across the United States.
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