D-0842-2020 Class II Terminated
FDA drug recall D-0842-2020 was initiated by Pfizer Inc. on February 5, 2020 and is designated Class II. 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. The recall status is terminated (terminated March 8, 2021). Affected quantity: 128 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 19, 2020
- Initiation Date
- February 5, 2020
- Termination Date
- March 8, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 128 bottles
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.
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.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot #: CY0963, Exp 07/2022