The Recall Desk
ModerateFDA (Drugs)·D-0022-2015·Announced 2014-10-22

Gyma Laboratories Recalls Propranolol HCl Due to Manufacturing Deviations

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

What this means for you

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 a GMP deviation without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Gyma Laboratories of America, Inc. is recalling Propranolol HCl, a chemical product for medicines preparation. The product is identified by NDC 012660-0004, Lot Number 154919, and an expiration date of 11/2014. It 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, which were manufactured in Italy, were produced in a manner that lacked good manufacturing practices (GMP).

This recall involves a prescription-only chemical product used for the preparation of medicines. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
Propranolol HCl, NET WT 1 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0004
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: 154919
  • Exp 11/2014

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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