Recalls / Class II
Class IID-1419-2022
Product
PEPCID COMPLETE CHEWABLE TAB BERRY 8CT SKU 903365 PEPCID AC MAXIMUM STRENGTH TABLET 25 CT SKU 902063 PEPCID AC MAXIMUM STRENGTH TABLET 8 CT SKU 914773 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
- Affected lot / code info
- SKUs: 903365; 902063; 914773
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-1419-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.