Why it was recalled
Subpotent Drug: Subpotent atorvastatin.
Product description
Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in a) 30 Count Bottles (NDC: 43598-315-30) and b) 90 Count Bottles (NDC: 43598-315-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India.
Lot numbers, UPCs & expiration codes
a) Lot #: C409650, Expiry: 05/2016; Lot #: C409652,Expiry: 05/2016. b) Lot #: C409652, Expiry: 05/2016
Where it was sold
U.S. 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-1378-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 13, 2015
- FDA report date
- Sep 2, 2015
- Quantity
- a) 16,848 and b) 216 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-1378-2015, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 71984
- Address
- 107 College Rd E
- Code information
- a) Lot #: C409650, Expiry: 05/2016; Lot #: C409652,Expiry: 05/2016. b) Lot #: C409652, Expiry: 05/2016
- Postal code
- 08540-6623
- Report date
- Sep 2, 2015
- Product type
- Drugs
- Recall number
- D-1378-2015
- Classification
- Class III
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- a) 16,848 and b) 216 Bottles
- Termination date
- Dec 15, 2016
- Reason for recall
- Subpotent Drug: Subpotent atorvastatin.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in a) 30 Count Bottles (NDC: 43598-315-30) and b) 90 Count Bottles (NDC: 43598-315-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India.
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Aug 13, 2015
- Initial firm notification
- Letter
- Center classification date
- Aug 27, 2015