Arbor Pharmaceuticals Recalls Subpotent Nymalize Oral Solution
Arbor Pharmaceuticals is voluntarily recalling Nymalize (nimodipine) oral solution because the drug is subpotent. The FDA classifies this as a Class III recall.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Arbor Pharmaceuticals Inc. is voluntarily recalling Nymalize (nimodipine) oral solution, 60 mg/20 mL, 12 Unit-Dose Cups and 12 Oral Syringes. The recall affects 1,846 cartons of the product, which is distributed nationwide within the United States. The specific lot number is 356884, with an expiration date of 11/30/2021.
The reason for the recall is that the drug is subpotent, meaning it does not contain the full amount of the active ingredient. The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
The recall was initiated on September 16, 2020, and was terminated on February 22, 2022. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be returned to the distributor or disposed of according to local regulations.
The recalled product
- Product
- Nymalize (nimodipine) oral solution, 60 mg/20 mL, 12 Unit-Dose Cups and 12 Oral Syringes, 2 inner cartons per outer shipping carton, Rx Only, Distributed by arbor Atlanta, GA, NDC 24338-200-12
- Manufacturer
- Arbor Pharmaceuticals Inc.
- Category
- Drug — Oral Solution
- Hazard
- Affected units
- 1,846
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 (1)
- Lot #: 356884 Exp. 11/30/2021
Distribution
Distributed nationwide across the United States.
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