The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0023-2015·Announced 2014-10-22

Gyma Recalls Clonidine Base Micronized Due to Manufacturing Deviations

Gyma Laboratories of America, Inc. is recalling Clonidine Base Micronized 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, which typically involves a temporary or medically reversible adverse health consequence. The source text cites cGMP deviations without reporting specific illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Gyma Laboratories of America, Inc. is recalling Clonidine Base Micronized, 55.8 Kg, Rx Only, S.I.M.S., Chemical Product for Medicines Preparation, Made in Italy, NDC 12660-0503-01. The affected lot numbers are 166247 and 166248, with an expiration date of 10/2016. The product is distributed nationwide.

The recall was initiated after the company received a Rapid Alert Notification from the Italian Medicines Agency. The notification indicated that the Active Pharmaceutical Ingredients were manufactured in Italy with a lack of good manufacturing practices (cGMP deviations).

This recall involves a chemical product used for medicines preparation. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates 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
Clonidine Base Micronized, 55.8 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 12660-0503-01
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 (3)

  • Lot Numbers: 166247
  • 166248
  • Exp 10/2016

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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