Recalls / Class II
Class IID-1434-2012
Product
Dr. Reddy's Amlodipine Besylate and Benazepril Hydrochloride 5 mg*/20 mg, 500 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325 INDIA, NDC 55111-340-05
- Brand name
- Amlodipine Besylate And Benazepril Hydrochloride
- Generic name
- Amlodipine Besylate And Benazepril Hydrochloride
- Active ingredients
- Amlodipine Besylate, Benazepril Hydrochloride
- Route
- Oral
- NDCs
- 55111-338, 55111-339, 55111-340, 55111-341
- FDA application
- ANDA077183
- Affected lot / code info
- C201293 Exp Date 08/2013
Why it was recalled
Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr.Reddy's Laboratories Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 200 Somerset Corporate Blvd Fl 7th, N/A, Bridgewater, New Jersey 08807-2862
Distribution
- Quantity
- 1656 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2012-04-09
- FDA classified
- 2012-07-31
- Posted by FDA
- 2012-08-08
- Terminated
- 2013-01-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1434-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.