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Class III: unlikely to cause harmTerminated

Sun Pharmaceutical Industries Clonazepam Orally Disintegrating Tablets Recall

Clonazepam Orally Disintegrating Tablets, USP, 0

SUN PHARMACEUTICAL INDUSTRIES INC · Princeton, NJ

Risk level
Class III
Reported by FDA
Aug 5, 2020
Recall ID
D-1445-2020
Check your lot numberHow we source this data

Summary

Sun Pharmaceutical Industries recalled Clonazepam Orally Disintegrating Tablets starting Jul 6, 2020. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1445-2020 on Aug 5, 2020. Reason: Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine. Status: Terminated.

Why it was recalled

Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine

Product description

Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-783-86

Lot numbers, UPCs & expiration codes

Lot #: AA84106, Exp 9/2021

Where it was sold

Nationwide 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-1445-2020
Classification
Class III
Status
Terminated
Recall initiated
Jul 6, 2020
FDA report date
Aug 5, 2020
Quantity
3516 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC

Original FDA data

Every field from FDA enforcement report D-1445-2020, exactly as published.

Show all FDA fields
City
Princeton
State
NJ
Status
Terminated
Country
United States
Event ID
85995
Address
2 Independence Way
Code information
Lot #: AA84106, Exp 9/2021
Postal code
08540-6620
Report date
Aug 5, 2020
Product type
Drugs
Recall number
D-1445-2020
Classification
Class III
Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Product quantity
3516 bottles
Termination date
Jun 8, 2023
Reason for recall
Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
Voluntary / mandated
Voluntary: Firm initiated
Product description
Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-783-86
Distribution pattern
Nationwide USA
Recall initiation date
Jul 6, 2020
Initial firm notification
Letter
Center classification date
Jul 30, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1445-2020, published Aug 5, 2020. View the source record (openFDA) · FDA enforcement reports

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

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