Why it was recalled
Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
Product description
Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/10 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Germany, NDC 0069-2160-30.
Lot numbers, UPCs & expiration codes
Lot #: CY0963, Exp 07/2022
Where it was sold
Nationwide in the USA.
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-0842-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 5, 2020
- FDA report date
- Feb 19, 2020
- Quantity
- 128 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0842-2020, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 84860
- Address
- 235 E 42nd St
- Code information
- Lot #: CY0963, Exp 07/2022
- Postal code
- 10017-5703
- Report date
- Feb 19, 2020
- Product type
- Drugs
- Recall number
- D-0842-2020
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- 128 bottles
- Termination date
- Mar 8, 2021
- Reason for recall
- Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/10 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Germany, NDC 0069-2160-30.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Feb 5, 2020
- Initial firm notification
- Letter
- Center classification date
- Feb 13, 2020