Why it was recalled
Subpotent drug
Product description
Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a)30-count bottle (NDC 43598-322-30), b) 90-count bottle (NDC 43598-322-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India
Lot numbers, UPCs & expiration codes
Lot #: a) C401536, Exp 07/2015; b) C401538, Exp 07/2015
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-1143-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 6, 2015
- FDA report date
- Jun 24, 2015
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-1143-2015, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 71375
- Address
- 107 College Rd E
- Code information
- Lot #: a) C401536, Exp 07/2015; b) C401538, Exp 07/2015
- Postal code
- 08540-6623
- Report date
- Jun 24, 2015
- Product type
- Drugs
- Recall number
- D-1143-2015
- Classification
- Class III
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Termination date
- Mar 31, 2016
- Reason for recall
- Subpotent drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a)30-count bottle (NDC 43598-322-30), b) 90-count bottle (NDC 43598-322-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India
- Distribution pattern
- Nationwide
- Recall initiation date
- May 6, 2015
- Initial firm notification
- Letter
- Center classification date
- Jun 18, 2015