Drug product
Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/20 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Germany, NDC 0069-2180-30.
D-0841-2020
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 84860
- Status
- Terminated
- Classification
- Class II
- Quantity
- 141 bottles
- Official record key
drug-enforcement:D-0841-2020
Official wording
Reason: 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.
Code information: Lot #: CY0937, Exp 12/2021
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Unknown
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.