Recalls / Class II
Class IID-0420-2019
Product
Progesterone 100 mg SR capsules, 30-180 capsules per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00311-2003-01
- Affected lot / code info
- N/A
Why it was recalled
Lack of Processing Controls.
Recalling firm
- Firm
- Duren Health Mart Pharmacy
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 215 Dexter L Woods Memorial Blvd, N/A, Waynesboro, Tennessee 38485-2416
Distribution
- Quantity
- 1306 capsules
- Distribution pattern
- TN only
Timeline
- Recall initiated
- 2018-12-17
- FDA classified
- 2019-01-28
- Posted by FDA
- 2019-02-06
- Terminated
- 2022-01-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0420-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.