Recalls / Class II
Class IID-0841-2020
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.
- Brand name
- Caduet
- Generic name
- Amlodipine Besylate And Atorvastatin Calcium
- Active ingredients
- Amlodipine Besylate, Atorvastatin Calcium Trihydrate
- Route
- Oral
- NDCs
- 0069-2260, 0069-2150, 0069-2170, 0069-2190, 0069-2160, 0069-2180, 0069-2250, 0069-2270, 0069-6180, 0069-6323 +6 more
- FDA application
- NDA021540
- Affected lot / code info
- Lot #: CY0937, Exp 12/2021
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.
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Pfizer Laboratories Div Pfizer Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 E 42nd St, New York, New York 10017-5703
Distribution
- Quantity
- 141 bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2020-02-05
- FDA classified
- 2020-02-13
- Posted by FDA
- 2020-02-19
- Terminated
- 2021-03-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0841-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.