Drug product
BANANA BOAT SPRT CLR SPRY SPF50 6 FL OZ SKU 2007524 SUNTONE SPORT SPRAY SPF 50 5.5 OZ SKU 2096102 HAWAIIAN TROPIC TANNING OIL SPRAY PUMP SPF 25 8 FL OZ SKU 2096111 BANANA BOAT SPORT ULTRAMIST SPRAY SPF 65 6 OZ SKU 2096117 COPPERTONE WATERBABIES LOTION SPF 50 8 FL OZ SKU 2097635 COPPERTONE SPORT SPRAY SPF 50 5.5 OZ SKU 2097636 BANANA BOAT SPRT LTION SPF 50 8 FL OZ SKU 2099592 HAWAIIAN TROPIC SHEER TOUCH LOTION SPF 30 8 FL OZ SKU 2006432 BB KIDS SUN SCREEN MIST SPRAY SPF 100 6 OZ SKU 2007523 SUNTONE KIDS SPRAY SPF 50 6 OZ SKU 2096096 NEUTROGENA BCH DFNSE SPR SPF 70 SKU 2097632 BANANA BOAT KDS SPRT SPRY SPF50 6FL OZ SKU 2097655 BANANA BOAT DRY OIL MST SPRY 15 SPF 6 OZ SKU 2097794 BANANA BOAT TAN DRY OIL MIST 4 SPF 6 OZ SKU 2097144 COPPERTONE GLOW SPRAY SPF 50 5OZ SKU 2096124 COPPERTONE SPORT LOTION SPF 50 8.75 FLOZ SKU 2096130 NEUTROGENA ULTRA SHEER LOTN SPF 55 3 FL OZ SKU 2097637 SUNTONE KIDS LOTION SPF 50 6 FL OZ SKU 2096101 BANANA BOAT SPORT ULTRA MIST 30 SPF 6 OZ SKU 2097141 COPPERTONE SPORT SPRAY SPF30 5.5OZ SKU 2097083 SUNTONE SPORT SPRAY SPF 70 5.5 OZ SKU 2008234 SUNTONE SPORT LOTION SPF 50 6 FL OZ SKU 2096099 COPPERTONE KIDS SPRAY SPF 50 5.5 OZ SKU 2097084 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
D-1365-2022
Product summary
- Event
- Event 90566
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unknown
- Official record key
drug-enforcement:D-1365-2022
Official wording
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Code information: SKUs: 2007524, 2096102, 2096111, 2096117, 2097635, 2097636, 2099592, 2007523, 2096096, 2097632, 2097655, 2097794, 2097144, 2096124, 2096130, 2097637, 2096101, 2097141, 2097083, 2008234, 2096099, 2097084; 2006432
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations