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Class II: temporary or reversible health riskTerminated

Cadila Pharmaceuticals Ondansetron HCI API Recall

Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd

Cadila Pharmaceuticals Limited

Risk level
Class II
Reported by FDA
Dec 7, 2016
Recall ID
D-0164-2017
Check your lot numberHow we source this data

Summary

Cadila Pharmaceuticals recalled Ondansetron HCI API starting Sep 9, 2016. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0164-2017 on Dec 7, 2016. Reason: Microbial Contamination of Non-Sterile Product. Status: Terminated.

Why it was recalled

Microbial Contamination of Non-Sterile Product

Product description

Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002

Lot numbers, UPCs & expiration codes

Supplied Batch, 150N004; Exp. 08/20 Supplied Batch, 150N006; Exp. 09/20

Where it was sold

According to the firm, the API distributed to two consignees in the US. See Consignee list below. Consignee List: 1). LLC LENS Phanna. Russia 2). Claris irljectable, Ahmedabad 3). CPL. Inc, USA

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-0164-2017
Classification
Class II
Status
Terminated
Recall initiated
Sep 9, 2016
FDA report date
Dec 7, 2016
Quantity
6.0kg
Recall type
Voluntary: Firm initiated
Recalling firm
Cadila Pharmaceuticals Limited

Original FDA data

Every field from FDA enforcement report D-0164-2017, exactly as published.

Show all FDA fields
City
Ankleshwar
Status
Terminated
Country
India
Event ID
75278
Address
294, G.I.D.C. Industrial Estate
Code information
Supplied Batch, 150N004; Exp. 08/20 Supplied Batch, 150N006; Exp. 09/20
Report date
Dec 7, 2016
Product type
Drugs
Recall number
D-0164-2017
Classification
Class II
Recalling firm
Cadila Pharmaceuticals Limited
Product quantity
6.0kg
Termination date
Jun 29, 2017
Reason for recall
Microbial Contamination of Non-Sterile Product
Voluntary / mandated
Voluntary: Firm initiated
Product description
Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002
Distribution pattern
According to the firm, the API distributed to two consignees in the US. See Consignee list below. Consignee List: 1). LLC LENS Phanna. Russia 2). Claris irljectable, Ahmedabad 3). CPL. Inc, USA
Recall initiation date
Sep 9, 2016
Initial firm notification
E-Mail
Center classification date
Dec 1, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0164-2017, published Dec 7, 2016. View the source record (openFDA) · FDA enforcement reports

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

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