The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0021-2015·Announced 2014-10-22

Gyma Recalls Dipyridamole API Due to Manufacturing Deviations

Gyma Laboratories of America, Inc. is recalling Dipyridamole API due to lack of good manufacturing practices identified by the Italian Medicines Agency.

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 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 recall is classified as FDA Class II and involves cGMP deviations without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Gyma Laboratories of America, Inc. has initiated a recall of Dipyridamole API, a chemical product used for medicines preparation. The specific product affected is Dipyridamole API, NET WT 10 Kg, Rx Only, S.I.M.S., with NDC 012660-0084. The recall covers Lot Number 161600, which has an expiration date of 03/2016.

The recall was triggered by the receipt of a Rapid Alert Notification from the Italian Medicines Agency. This notification indicated that the active pharmaceutical ingredients, which were manufactured in Italy, were produced in violation of good manufacturing practices (cGMP). The distribution of the affected product was nationwide.

Consumers and healthcare providers should check their inventory for this specific lot number and NDC. If found, the product should be discontinued and returned to the supplier or the recalling firm, Gyma Laboratories of America, Inc. This recall is classified as Class II by the FDA.

The recalled product

Product
Dipyridamole API, NET WT 10 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0084
Manufacturer
Gyma Laboratories Of Amer,Inc
Category
Drug — Active Pharmaceutical Ingredient
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 (2)

  • Lot Number: 161600
  • Exp 03/2016

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Gyma Laboratories Of Amer,Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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