Recalls / Class II
Class IID-0751-2018
Product
Orkambi 100 mg/125 mg Tablets #112 NDC 51167-0700-02 28 days supply.
- Affected lot / code info
- All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Why it was recalled
Lack of Processing Controls.
Recalling firm
- Firm
- Kroger Specialty Pharmacy, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 Pear Orchard Dr Ste A, N/A, Vicksburg, Mississippi 39180-7153
Distribution
- Quantity
- Unknown
- Distribution pattern
- MS, LA, AR, IL, FL
Timeline
- Recall initiated
- 2018-04-03
- FDA classified
- 2018-05-10
- Posted by FDA
- 2018-05-16
- Terminated
- 2020-05-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0751-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.