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Class II: temporary or reversible health riskTerminated

Wockhardt Amlodipine Besylate Tablets Recall

Amlodipine Besylate Tablets, 5 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-…

Wockhardt Usa Inc. · Parsippany, NJ

Risk level
Class II
Reported by FDA
Jul 29, 2015
Recall ID
D-1255-2015
Check your lot numberHow we source this data

Summary

Wockhardt recalled Amlodipine Besylate Tablets starting Apr 22, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1255-2015 on Jul 29, 2015. Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. Status: Terminated.

Why it was recalled

CGMP Deviations: Firm did not adequately investigate customer complaints.

Product description

Amlodipine Besylate Tablets, 5 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-422-01) and B) 1000 Count Bottles (NDC: 64679-422-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Lot numbers, UPCs & expiration codes

A) Lot #: DM11421, Expiry: 5/31/2015; Lot #: DM12956, Expiry: 10/31/2015; Lot #: DM12957, Expiry: 10/31/2015; Lot #: DM12963, Expiry: 10/31/2015; Lot #: DM13242, Expiry: 11/30/2015; Lot #: DM13243, Expiry: 11/30/2015; Lot #: DM13251, Expiry: 11/30/2015; Lot #: DM13260, Expiry: 11/30/2015; Lot #: DN10138, Expiry: 12/31/2015. B) Lot #: DM11035, Expiry: 4/30/2015; Lot #: DM11088, Expiry: 4/30/2015; Lot #: DM11389, Expiry: 5/31/2015; Lot #: DM11393, Expiry: 5/31/2015; Lot #: DM11394, Expiry: 5/31/2015; Lot #: DM12632, Expiry: 9/30/2015; Lot #: DM12633, Expiry: 9/30/2015; Lot #: DM12650, Expiry: 9/30/2015; Lot #: DM12651, Expiry: 9/30/2015; Lot #: DM12667, Expiry: 5/31/2015; Lot #: DM12964, Expiry: 10/31/2015; Lot #: DM13086, Expiry: 10/31/2015; Lot #: DM13155, Expiry: 10/31/2015; Lot #: DM13156, Expiry: 10/31/2015; Lot #: DM13157, Expiry: 10/31/2015; Lot #: DM13158, Expiry: 10/31/2015; Lot #: DM13184, Expiry: 10/31/2015; Lot #: DM13206, Expiry: 10/31/2015; Lot #: DM13207, Expiry: 10/31/2015; Lot #: DM13266, Expiry: 11/30/2015; Lot #: DM13267, Expiry: 11/30/2015; Lot #: DM13268, Expiry: 11/30/2015; Lot #: DM13283, Expiry: 11/30/2015; Lot #: DM13325, Expiry: 11/30/2015; Lot #: DN10058, Expiry: 12/31/2015; Lot #: DN10059; Expiry: 12/31/2015; Lot #: DN10060, Expiry: 12/31/2015; Lot #: DN10061, Expiry: 12/31/2015; Lot #: DN10062, Expiry: 12/31/2015; Lot #: DN10307, Expiry: 12/31/2015; Lot #: DN10308, Expiry: 12/31/2015; Lot #: DN10324, Expiry: 12/31/2015; Lot #: DN10346, Expiry: 12/31/2015; Lot #: DN10809, Expiry: 2/29/2016; Lot #: DN10810, Expiry: 2/29/2016; Lot #: DN10840, Expiry: 2/29/2016; Lot #: DN10877, Expiry: 2/29/2016; Lot #: DN10878, Expiry: 2/29/2016; Lot #: DN10904, Expiry: 2/29/2016; Lot #: DN10905, Expiry: 2/29/2016; Lot #: DN10921, Expiry: 2/29/2016; Lot #: DN10942, Expiry: 3/31/2016; Lot #: DN10943, Expiry: 3/31/2016; Lot #: DN10972, Expiry: 3/31/2016.

Where it was sold

U.S. Nationwide including Puerto Rico.

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-1255-2015
Classification
Class II
Status
Terminated
Recall initiated
Apr 22, 2015
FDA report date
Jul 29, 2015
Quantity
A) 146,959 Bottles, B) 73,445 Bottles.
Recall type
Voluntary: Firm initiated
Recalling firm
Wockhardt Usa Inc.

Original FDA data

Every field from FDA enforcement report D-1255-2015, exactly as published.

Show all FDA fields
City
Parsippany
State
NJ
Status
Terminated
Country
United States
Event ID
71104
Address
20 Waterview Blvd Ste 3
Code information
A) Lot #: DM11421, Expiry: 5/31/2015; Lot #: DM12956, Expiry: 10/31/2015; Lot #: DM12957, Expiry: 10/31/2015; Lot #: DM12963, Expiry: 10/31/2015; Lot #: DM13242, Expiry: 11/30/2015; Lot #: DM13243, Expiry: 11/30/2015; Lot #: DM13251, Expiry: 11/30/2015; Lot #: DM13260, Expiry: 11/30/2015; Lot #: DN10138, Expiry: 12/31/2015. B) Lot #: DM11035, Expiry: 4/30/2015; Lot #: DM11088, Expiry: 4/30/2015; Lot #: DM11389, Expiry: 5/31/2015; Lot #: DM11393, Expiry: 5/31/2015; Lot #: DM11394, Expiry: 5/31/2015; Lot #: DM12632, Expiry: 9/30/2015; Lot #: DM12633, Expiry: 9/30/2015; Lot #: DM12650, Expiry: 9/30/2015; Lot #: DM12651, Expiry: 9/30/2015; Lot #: DM12667, Expiry: 5/31/2015; Lot #: DM12964, Expiry: 10/31/2015; Lot #: DM13086, Expiry: 10/31/2015; Lot #: DM13155, Expiry: 10/31/2015; Lot #: DM13156, Expiry: 10/31/2015; Lot #: DM13157, Expiry: 10/31/2015; Lot #: DM13158, Expiry: 10/31/2015; Lot #: DM13184, Expiry: 10/31/2015; Lot #: DM13206, Expiry: 10/31/2015; Lot #: DM13207, Expiry: 10/31/2015; Lot #: DM13266, Expiry: 11/30/2015; Lot #: DM13267, Expiry: 11/30/2015; Lot #: DM13268, Expiry: 11/30/2015; Lot #: DM13283, Expiry: 11/30/2015; Lot #: DM13325, Expiry: 11/30/2015; Lot #: DN10058, Expiry: 12/31/2015; Lot #: DN10059; Expiry: 12/31/2015; Lot #: DN10060, Expiry: 12/31/2015; Lot #: DN10061, Expiry: 12/31/2015; Lot #: DN10062, Expiry: 12/31/2015; Lot #: DN10307, Expiry: 12/31/2015; Lot #: DN10308, Expiry: 12/31/2015; Lot #: DN10324, Expiry: 12/31/2015; Lot #: DN10346, Expiry: 12/31/2015; Lot #: DN10809, Expiry: 2/29/2016; Lot #: DN10810, Expiry: 2/29/2016; Lot #: DN10840, Expiry: 2/29/2016; Lot #: DN10877, Expiry: 2/29/2016; Lot #: DN10878, Expiry: 2/29/2016; Lot #: DN10904, Expiry: 2/29/2016; Lot #: DN10905, Expiry: 2/29/2016; Lot #: DN10921, Expiry: 2/29/2016; Lot #: DN10942, Expiry: 3/31/2016; Lot #: DN10943, Expiry: 3/31/2016; Lot #: DN10972, Expiry: 3/31/2016.
Postal code
07054-1271
Report date
Jul 29, 2015
Product type
Drugs
Recall number
D-1255-2015
Classification
Class II
Recalling firm
Wockhardt Usa Inc.
Product quantity
A) 146,959 Bottles, B) 73,445 Bottles.
Termination date
May 9, 2018
Reason for recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Amlodipine Besylate Tablets, 5 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-422-01) and B) 1000 Count Bottles (NDC: 64679-422-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
Distribution pattern
U.S. Nationwide including Puerto Rico.
Recall initiation date
Apr 22, 2015
Initial firm notification
Letter
Center classification date
Jul 17, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1255-2015, published Jul 29, 2015. View the source record (openFDA) · FDA enforcement reports

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

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