FindMyRecallSubscribe
Class II: temporary or reversible health riskTerminated

Gyma Laboratories Of Amer Dipyridamole API Recall

Dipyridamole API

Gyma Laboratories Of Amer,Inc · Westbury, NY

Risk level
Class II
Reported by FDA
Oct 22, 2014
Recall ID
D-0021-2015
Check your lot numberHow we source this data

Summary

Gyma Laboratories Of Amer recalled Dipyridamole API starting Jul 9, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0021-2015 on Oct 22, 2014. Reason: cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices. Status: Terminated.

Why it was recalled

cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.

Product description

Dipyridamole API, NET WT 10 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0084

Lot numbers, UPCs & expiration codes

Lot Number: 161600, Exp 03/2016

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0021-2015
Classification
Class II
Status
Terminated
Recall initiated
Jul 9, 2014
FDA report date
Oct 22, 2014
Quantity
10 Kg
Recall type
Voluntary: Firm initiated
Recalling firm
Gyma Laboratories Of Amer,Inc

Original FDA data

Every field from FDA enforcement report D-0021-2015, exactly as published.

Show all FDA fields
City
Westbury
State
NY
Status
Terminated
Country
United States
Event ID
69243
Address
135 Cantiague Rock Rd
Code information
Lot Number: 161600, Exp 03/2016
Postal code
11590-2826
Report date
Oct 22, 2014
Product type
Drugs
Recall number
D-0021-2015
Classification
Class II
Recalling firm
Gyma Laboratories Of Amer,Inc
Product quantity
10 Kg
Termination date
Jun 4, 2018
Reason for recall
cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Dipyridamole API, NET WT 10 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0084
Distribution pattern
Nationwide
Recall initiation date
Jul 9, 2014
Initial firm notification
E-Mail
Center classification date
Oct 10, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0021-2015, published Oct 22, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

How we source and update recall data · Report incorrect information

Other recent drug recalls