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.
Product description
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
Lot numbers, UPCs & expiration codes
C201293 Exp Date 08/2013
Where it was sold
Nationwide and 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-1434-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 9, 2012
- FDA report date
- Aug 8, 2012
- Quantity
- 1656 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-1434-2012, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 62591
- Address
- 200 Somerset Corporate Blvd Fl 7th
- Code information
- C201293 Exp Date 08/2013
- Postal code
- 08807-2862
- Report date
- Aug 8, 2012
- Product type
- Drugs
- Recall number
- D-1434-2012
- Classification
- Class II
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 1656 bottles
- Termination date
- Jan 24, 2013
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Apr 9, 2012
- Initial firm notification
- Letter
- Center classification date
- Jul 31, 2012