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Class II: temporary or reversible health riskTerminated

Zydus Pharmaceuticals PROMETHAZINE HYDROCHLORIDE Tablets Recall

PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only

Zydus Pharmaceuticals USA Inc · Pennington, NJ

Risk level
Class II
Reported by FDA
May 28, 2014
Recall ID
D-1342-2014
Check your lot numberHow we source this data

Summary

Zydus Pharmaceuticals recalled PROMETHAZINE HYDROCHLORIDE Tablets starting May 8, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1342-2014 on May 28, 2014. Reason: Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles. Status: Terminated.

Why it was recalled

Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.

Product description

PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. Manufactured by: Cadila Healthcared Ltd., India. Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534. NDC: 68382-041-01

Lot numbers, UPCs & expiration codes

Lot #: MN9081, Expiry: 09/2015

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-1342-2014
Classification
Class II
Status
Terminated
Recall initiated
May 8, 2014
FDA report date
May 28, 2014
Quantity
10,200 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Zydus Pharmaceuticals USA Inc

Original FDA data

Every field from FDA enforcement report D-1342-2014, exactly as published.

Show all FDA fields
City
Pennington
State
NJ
Status
Terminated
Country
United States
Event ID
68285
Address
73 Route 31 N
Code information
Lot #: MN9081, Expiry: 09/2015
Postal code
08534-3601
Report date
May 28, 2014
Product type
Drugs
Recall number
D-1342-2014
Classification
Class II
Recalling firm
Zydus Pharmaceuticals USA Inc
Product quantity
10,200 bottles
Termination date
Feb 26, 2016
Reason for recall
Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
Voluntary / mandated
Voluntary: Firm initiated
Product description
PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. Manufactured by: Cadila Healthcared Ltd., India. Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534. NDC: 68382-041-01
Distribution pattern
Nationwide
Recall initiation date
May 8, 2014
Initial firm notification
Letter
Center classification date
May 21, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1342-2014, published May 28, 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.

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