The Recall Desk
LowFDA (Drugs)·D-1625-2020·Announced 2020-10-07

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.

What this means for you

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
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.