Recalls / Class II
Class IID-1417-2022
Product
GOOD SENSE OMEPRAZOLE TABLET 14CT SKU 900055 PRILOSEC OTC TABLET 14 CT SKU914128 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
- Affected lot / code info
- SKUs: 900055; 914128
Why it was recalled
CGMP Deviations: product held outside appropriate storage temperature conditions.
Recalling firm
- Firm
- Family Dollar Stores, Llc.
- Notification channel
- Other
- Type
- Voluntary: Firm initiated
- Address
- 500 Volvo Pkwy, Chesapeake, Virginia 23320-1604
Distribution
- Quantity
- Unknown
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2022-06-23
- FDA classified
- 2022-08-22
- Posted by FDA
- 2022-08-31
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-1417-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.