The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0024-2015·Announced 2014-10-22

Gyma Laboratories Recalls Clonidine HCL Due to Manufacturing Deviations

Gyma Laboratories of America, Inc. is recalling Clonidine HCL chemical product for medicines preparation due to lack of good manufacturing practices.

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 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 HCL, 97 Kg, Rx Only, S.I.M.S., Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0002. The affected lot numbers are 167219, 163367, 167220, and 167221, with an expiration date of 03/2017. The product was distributed nationwide.

The recall was initiated after the U.S. Food and Drug Administration 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 the preparation of medicines. Consumers and healthcare providers should check their inventory for the specific lot numbers listed above. If you have this product, you should stop using it and contact the recalling firm or your supplier for instructions on return or disposal.

The recalled product

Product
Clonidine HCL, 97 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0002
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 (5)

  • Lot Numbers: 167219
  • 163367
  • 167220
  • 167221
  • Exp 03/2017

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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