Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1430-2022 | 06-23-2022 | MEDIC EYE DROPS MAX REDNESS SKU 998920 CLR EYS MX RDNS RLIF 0.5 FL OZ SKU 901844 SYSTANE ULTRA HIGH PRFRM LUB DRPS 0.14 FLOZ SKU 901961 LUMIFY REDNESS REL EYE DROPS 2.5 FL OZ SKU 998300 FC EYE DROPS ADVANCED 0.5 OZ SKU 902280 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1419-2022 | 06-23-2022 | 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. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1408-2022 | 06-23-2022 | TN DICKINSON WITCH HAZEL 16 FL OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1426-2022 | 06-23-2022 | GC MILK OF MAGNESIA CHERRY 12 FL OZ SKU 915000 GC MILK OF MAGNESIA MINT 12 FL OZ SKU 915623 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1400-2022 | 06-23-2022 | ZZZQUIL NIGHT PAIN BERRY 12 FL OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1363-2022 | 06-23-2022 | Novelty Hand Sanitizer with Silicone Wrap SKU 998890 Novelty Hand Sanitizer Assorted SKU 999330 Purell Hand Sanitizer Essentials 1 FL OZ SKU 2006819 Luxury Hand Sanitizer 16.9 FL OZ SKU 2007723 Suave Hand Sanitizer Lotion 3 FL OZ SKU 2096469 Purell Hand Sanitizer Original 6.5 FL OZ SKU 2095985 Purell Hand Sanitizer Soothing Aloe 6.5 Fluid Ounces SKU 2095986 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1398-2022 | 06-23-2022 | AZO YEAST PLUS 20 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1421-2022 | 06-23-2022 | RIC STOOL SOFTENER SOFTGEL 100 CT SKU 917000 RIC STOOL SOFTNER 100 CT SKU 902493 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1381-2022 | 06-23-2022 | ORAJEL GUM PAIN RELIEF GEL 0.125OZ SKU 903432 GOOD SENSE ORAL PAIN RELIEF 0.5OZ SKU 999543 ORAJEL ORAL PAIN 0.125 FL OZ SKU 912968 ORAJEL MOUTH SORE GEL 0.125 OZ SKU 999075 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1445-2022 | 06-23-2022 | NICORETTE GUM WHITE ICE MINT 4 MG 20 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1425-2022 | 06-23-2022 | QP LAXATIVE BISACODYL 5 MG TABLET 50 CT SKU 902449 QP WOMEN LAXATIVE BISCODYL TABLET 25 CT SKU 915221 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1373-2022 | 06-23-2022 | MOTRIN IB CAPLETS 24CT SKU999394; GOOD SENSE IBUPROFEN 200MG TABLETS 24CT SKU 900556;GOOD SENSE IBUPROFEN 200MG CAPLET 50 CT SKU 902333 MOTRIN CHILDREN'S BUBBLEGUM 4 FL OZ SKU 903048 GOOD SENSE IBUPROFEN REGULAR SOFTGELS 160CT SKU 999373 GOOD SENSE IBUPROFEN 200 MG CAPLET 100 CT SKU 902359 MOTRIN IB CAPLET 50 CT SKU 900604 GOOD SENSE IBUPROFEN IB CAPLET 100 CT SKU 913989 GOOD SENSE IBUPROFEN 200 MG SOFTGEL 20CT SKU 916994 ADVIL LIQUID GEL 40 CT SKU 916071 GOOD SENSE IBUPROFEN PM 200 MG 20 CT SKU 917004 ADVIL PM CAPLET 20CT SKU 913010 GOOD SENSE IBUPROFEN TABLET 100 CT SKU 913991 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Specifically: | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / | Class II | Ongoing |
| D-1386-2022 | 06-23-2022 | DESITIN CREAMY OINTMENT 2 FL OZ SKU 912976 BABY LOVE OINTMENT CREAM 4 OZ SKU 902617 DESITIN MAXIMUM STRENGTH PASTE 4 OZ SKU 903097 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1438-2022 | 06-23-2022 | CARMEX DAILY CARE CHERRY SPF 15 0.35 OZ SKU 901842 CARMEX LIP BALM JAR 0.25OZ SKU 903284 CARMEX STRWBRRY STCK W SPF 15 0.15OZ SKU 905760 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1462-2022 | 06-23-2022 | VICKS DAYQUIL NYQUIL LIQ COMB PK 6 FLOZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1422-2022 | 06-23-2022 | READY IN CASE RUBBING ALCOHOL 91 PCT 16 FL OZ SKU 902270 READY IN CASE 70 PCT ISOPROPYL ALCOHOL 32 FL OZ SKU 999747 READY IN CASE 91PCT ISOPROPYL ALCOHOL 32 FL OZ SKU 999742 READY IN CASE 70PCT ISOPROPYL ALCOHOL 16 FL OZ SKU 999743 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1402-2022 | 06-23-2022 | SWAN PETROLEUM JELLY 7.5 OZ SKU 910721 BABY LOVE PETROLEUM JELLY 13 OZ SKU 910726 VASELINE PETROLEUM JELLY ORIGINAL 7.5 OZ 2099273 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1428-2022 | 06-23-2022 | FLEET GLYCERIN SUPPOSITORIES 50 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1437-2022 | 06-23-2022 | BLISTEX LIP MEDEX 0.25OZ SKU 906120 BLISTEX LIP MEDEX POT 0.38 OZ SKU 998852 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1418-2022 | 06-23-2022 | GOOD SENSE ESOMEPRAZOLE ACID REDUCER 20MG 42CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1382-2022 | 06-23-2022 | ORAJEL NON MED TEETHING GEL 0.125 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1392-2022 | 06-23-2022 | READY IN CASE PAIN RELIEVER PM CAPLET 100 CT SKU 902381 GOOD SENSE PAIN RELIEVER APAP 500MG CAPLET 250CT SKU 902332 READY IN CASE PM PAIN RELIEVER CAPLET 50 CT SKU 913982 GOOD SENSE PAIN RELIEVER APAP ES 500 CT SKU 999029 GOOD SENSE PAIN RELIEVER CAPLET 100 CT SKU 913890 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1443-2022 | 06-23-2022 | GOOD SENSE LICE SHAMPOO 6FL OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1435-2022 | 06-23-2022 | ARTHRITIS HOT CREME 3 OZ SKU 901452 ICY HOT PATCH 1 CT SKU 911030 ICY HOT MUSCLE RUB 1.25 OZ SKU 920205 ICY HOT NO MESS 1.5 OZ SKU 998751 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1420-2022 | 06-23-2022 | PREVACID 24HR LANSOPRAZOLE 15MG CAP 14CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1436-2022 | 06-23-2022 | ASPERCREME WITH LIDOCAINE CREME 1.75 OZ SKU 999852 ICY HOT LIDOCAINE CREAM 1.75 OZ SKU 999853 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1401-2022 | 06-23-2022 | JET ALERT TABLET 30 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1403-2022 | 06-23-2022 | MY CHOICE LEVONORGESTREL TABLET distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1387-2022 | 06-23-2022 | AD PREV OINT ORIG 4 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1383-2022 | 06-23-2022 | NPX TRIPLE ANTIBIOTIC OINTMENT 1 OZ SKU 910320 NPX PAIN ITCH SCAR ANTIBAC OINTMENT 1 OZ SKU 999855 NPX TRPL ANTIBIOTIC PLS PAIN OINMNT 1 OZ SKU 901498 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1417-2022 | 06-23-2022 | 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. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1448-2022 | 06-23-2022 | GUARDIAN BISMUTH CHWBLE CHRY TABS 30 CTSKU 902321 RIC BISMUTH MAXIMUM STRENGTH 8 FL OZ SKU 914325 PEPTO BISMOL ORIGINAL 8 FL OZ SKU 914324 RIC BISMUTH REG STRENGTH CHERRY 8 FL OZ SKU 914781 PEPTO BISMOL CHERRY 8 FL OZ SKU 916063 PEPTO B LIQUID ORIGINAL TRAVEL 3.4 FL OZ SKU 999812 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1370-2022 | 06-23-2022 | SUAVE INV SLD PWDR 1.2 OZ SKU2004504 SUAVE AP INV SOLID SWEET PEA 1.2 OZ SKU 2004622 LADY SPEED STICK AP WILD FREESSIA 1.4OZ SKU 2005184 SUAVE AP DEOD POWDER 2.6 OZ 2PK SKU 2028126 SCRT IN SLD PWDR FRSH 2.1OZ 2PK SKU 2028363 LADY SPD STK AP INV PWDR 1.4OZ SKU 2028365 DEGREE INV SLD XBLST 2.7 OZ 2PK SKU 2028378 SECRET DEO INV SHWR FRSH 2.1 OZ SKU 2028538 SUAVE DEO TRPCL PARADISE 1.2 OZ SKU 2028544 SECRET DS WHTE PECH ARGN OIL SPRY 4.1 OZ SKU 2095889 SECRET DS WILD ROSE OIL SPRAY 4.1 OZ SKU 2095896 DOVE ADVANCED COOL ESSENTIALS 2.6OZ SKU 2099968 OLD SPICE RED ZONE DEO SWAGGER 3OZ SKU 2005168 OLD SPICE HE FRESH DEO 2.4OZ 2PK SKU 2007730 SECRET OUTLAST CLEAN LVNDR GEL 2.6OZ SKU 2098900 OLD SPICE WC IS BEARGLOVE 2.6OZ SKU 2099254 DEGREE FMAL BLCK WHT PURERN DRYSPRY3.8OZ SKU 2003471 DEGREE EXTREME BLAST IS 2.7 OZ SKU 2005214 SECRET FRESH IS COCOA BUTTER 2.6OZ SKU 2007898 SECRET OUTLAST IS COMPLETELY CLEAN 2.6OZ SKU 2001333 DEGREE ML INVIS SLD COOL RUSH 1.7OZ SKU 2002557 OLD SPICE RZ SWAGGER 2.6 OZ SKU 2004512 DOVE AP INV SLD FRESH 1.6 OZ SKU 2028253 DEGREE FOR WOMEN IS BW PURE RAIN 2.6 OZ SKU 2096622 DEGREE BLCK WHIT PURE CLN DRY SPRY 3.8 OZ SKU 2003471 DEGREE MEN INV SLD SPORT TWIN 2.7 OZ 2PK SKU 2001309 SECRET INVS SLD PWDR FRSH 2.1 OZ SKU 2028310 DOVE ADVANCED CARE IS COCONUT 2.6 OZ SKU 2006902 SECRET FRESH EXP PARIS ROSE GEL 2.6 OZ SKU 2098479 OLD SPICE FIJI 2.6OZ SKU 2001336 SECRET AP STICK FRSH PWD 1.7OZ SKU 2028566 DOVE MEN AP INV SLD XTRA FRSH 2.7 OZ SKU SECRET OUTLAST CLR GEL PWDR PROTEC 2.6OZ SKU 2044343 DOVE CARING COCONUT DRY SPRAY 3.8OZ SKU 2097527 DOVE CLR FNSH 100 CLRS DRY SPR 3.8FLOZ SKU 2098905 AXE AP INV SLD DK TEMPT 2.7OZ SKU 2028222 DOVE DRY SPRAY COOL ESSENTIALS 3.8 OZ L2 SKU 2006098 DEGREE FMLE INV SLD TWN PWDR 2.6 OZ 2PK SKU 2001311 OLD SPICE HE PLAYMAKER 2.4 OZ SKU 2004835 GIL CLEAR GEL COOL WAVE 2.85 OZ 2PK SKU 2005220 DEGREE WMNS SEXY INTRIGUE 2.6 OZ SKU 2028194 MENNEN SPEED STCK AP INV SLD FRSH 1.8 OZ SKU 2028249 DOVE INV SLD POWDER 1.6 OZ SKU 2028255 DEGREE AP INV SLD XBLAST 1.7 OZ SKU 2028257 AH ULTRAMAX INV SLD FRSH SCT 1 OZ SKU 2028315 POWER STICK LADY AP POWDER FRESH 1.7 OZ SKU 2044190 DOVE MENS INV SOLID CLEAN COMFORT 1.7 OZ SKU 2097528 AXE APOLLO INV SOLID DEODORANT 1.7 OZ SKU 2097534 DEGREE AP INV SLD FRESH 2.6OZ SKU 2028218 SUAVE AP INV SLD TRPCL PARDSE 2.6 OZ SKU 2004752 DEGREE AP INV SLD SHOWR 1.6 OZ SKU 2028258 SUAVE MENS ACTIVE SPORT 2.7OZ SKU 2098472 OLD SPICE INV SLD KRAKENGARD 2.6OZ SKU 2098901 AXE ANARCHY INVISIBLE SOLID 2.7 OZ SKU 2005211 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown. | Class II | Ongoing |
| D-1416-2022 | 06-23-2022 | MYLANTA MAX STRENGTH CLASSIC FLVR 12 FLOZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1396-2022 | 06-23-2022 | PREFERRED URINRY PN RLF MAX STRNGTH 12 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1439-2022 | 06-23-2022 | MIDOL COMPLETE CAPLET 16 CT SKU 913028 QP MENSTRUAL RELIEF COMPLETE CAPLET 16CT SKU 999982 QP PMS FORMULA CAPLET 32 CT SKU 913232 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1415-2022 | 06-23-2022 | ALKA SELTZER EXTRA STRENGTH 24 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1377-2022 | 06-23-2022 | DIAL MENS EUCALYPTUS AB BODY WASH 20 FLOZ SKU 2096030 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1380-2022 | 06-23-2022 | Orajel Cold Sore Pain Cream 1.25 fl. oz. distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1431-2022 | 06-23-2022 | ST IVES BLKHD CLRNG GREEN TEA SCRUB 6 OZ SKU 2007787 AMBI EXFOLIATING WASH 5 OZ SKU 2097153 CC BLACKHEAD SCRUB 5 OZ SKU 2032021 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1423-2022 | 06-23-2022 | DRX FIBER CAPSULES 100 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1409-2022 | 06-23-2022 | DOCTOR TEALS PURE EPSOM SALT UNSCENTED 6 LBS SKU 999355 Ready in case EPSOM SALTS 2 LB SKU 909223 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1442-2022 | 06-23-2022 | MYLICON INFANT GAS DROPS 0.5 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1452-2022 | 06-23-2022 | READY IN CASE CTRZNE ALRGY ALL DY TBLT 5 CT SKU 900448 ZYRTEC CHILDRENS GRAPE 4 FL OZ SKU 999368 GOOD SENSE ALLERGY CETIRIZINE 10 MG TABLET 14 CT SKU 916897 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1371-2022 | 06-23-2022 | SOFTSOAP ANTI BACTRIAL LQ SOAP 11.25 FLOZ SKU 2005090 DIAL LHS WHITE TEA AND VITAMIN E 7.5FLOZ SKU 2007700 SOFTSOAP LHS CC ANTIBAC ORANGE 50 FL OZ SKU 2007708 SPA SOAP ANTIBAC GLD LHS PUMP 20.2 FL OZ SKU 2097440 DIAL FOAMING LHS POWER BERRIES 7.5 FL OZ SKU 2044098 SOFTSOAP LIQUID HAND SOAP FERSH CITRUS AB 11.25 FL OZ SKU 2005088 SPA SOAP HNDSP ANTBCTRL ULTR2X GLD 64 FL OZ SKU 2008290 DIAL FOAMING LHS SPRING WATER 7.5 FL OZ SKU 2044177 DAWN ULTRA ANTIBAC APL BLOSSOM 21.6 FLOZ SKU 1498425 DAWN ULTRA APPLE 15.5 FL OZ SKU 1414227 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1384-2022 | 06-23-2022 | FS HYDROCORTISONE CREAM 1 OZ SKU 910321 CORTIZONE 10 CREME 0.5 OZ SKU 910167 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1375-2022 | 06-23-2022 | DR SCHOLLS ANTI FUNGAL SPRAY PWDER 4.7 OZ SKU 998250 PREMIER ANTFGL TLNFTT LQ SPRY 5.3 FL OZ SKU 911077 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1372-2022 | 06-23-2022 | Ready in case ACETAMINOPHEN PM CAPLETS 24 CT SKU 900559; TYLENOL CHILD GRAPE 4 FL OZ SKU 901600 TYLENOL CHILD ORAL SUSPENSION CHERRY 4 FO 913104 TYLENOL INFANTS DROPS DF CHERRY 1OZ SKU 999108 TYLENOL PM CAPLET 24 CT SKU 900603 TYLENOL EXTRA STRENGTH CAPLET 24 CT SKU 916986 TYLENOL 8HR MSL ACHE PAIN RD CAPLET 24 CT SKU 901155 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1457-2022 | 06-23-2022 | MUCINEX FASTMAX CAPLETS COLD FLU 4CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1444-2022 | 06-23-2022 | AFRIN NO DRIP SEVERE CONGESTION 0.5FL OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1410-2022 | 06-23-2022 | SWAN POVIDONE 4 FL OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1412-2022 | 06-23-2022 | GOOD SENSE SORE THROAT SPRAY CHERRY 6 FL OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1391-2022 | 06-23-2022 | BC POWDER 50 CT SKU 901588 BC POWDER 18 CT SKU 913228 GOODYS POWDER 50 CT SKU 901589 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1450-2022 | 06-23-2022 | QP DPHNHDRME ALRGY MIN TBLT 12 CT SKU 900449 QP ALLERGY DIPHENHYDRAMINE 25 MG 48 CT SKU 916003 QP ALLERGY MULTI SYMPTOM CAPLET 24CT SKU 916918 BENADRYL D CHILD ALLERGY SINUS GRAPE 4FO SKU 901738 GOOD SENSE CHILD ALLERGY CHERRY 4 FL OZ SKU 916917 BENADRYL ALLERGY CONGESTN ULTRA TAB 24CT SKU 999834 BENADRYL ALLERGY ULTRATAB 24CT SKU 902217 BENADRYL ALLERGY LIQUIDGELS 24 CT SKU 916715 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1441-2022 | 06-23-2022 | STYE EYE OINTMENT 0.125 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1413-2022 | 06-23-2022 | VASELINE ECZEMA CALMING THERPY CRM 6.8 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1389-2022 | 06-23-2022 | LIDOCAINE ARTHRITIS AND SPORT WNTGRN 16 FLOZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1461-2022 | 06-23-2022 | QP COUGH COLD TABLET 16 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1449-2022 | 06-23-2022 | GS ANTI DIARRHEAL LOPERAMIDE CAPLET 12 CT SKU 915632 IMODIUM AD MINT 4 OZ SKU 902080 IMODIUM AD CAPLET 6 CT SKU 915628 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1399-2022 | 06-23-2022 | VICKS VAPOCOOL DROPS SEVERE 18 CT SKU 999488 BEST HEALTH HONEY LEMON COUGH DROP 80 CT SKU 998844 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1451-2022 | 06-23-2022 | CLARITIN ALLERGY LIQ CHLDRNS GRAPE 2 FLOZ SKU 900834 CLARITIN ALLERGY 10MG TABLETS 5 CT SKU 916116 GS ALLERGY LORATADINE TABLET 30 CT SKU 916114 CLARITIN ALLERGY 10 MG TABLET 10 CT SKU 901655 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1394-2022 | 06-23-2022 | VICKS VAPORUB 1.76 OZ SKU 919667 VICKS VAPOR RUB LAVENDER 1.76 OZ 999813 SWAN MEDICATED CHEST RUB 3.53 OZ SKU 920611 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1367-2022 | 06-23-2022 | COLGATE MAX FRESH CLEAN MINT 1.9OZ SKU 900596 COLGATE CAVITY PROTECTION 6OZ 3PK SKU 900734 SENSODYNE REPAIR AND PROTCT WHITNG 3.4 OZ SKU 901003 COLGATE BSPW PASTE BRISK MINT 6 OZ 2PK SKU 901658 COLGATE MAX FRESH COOL MINT 6OZ 2PK SKU 901785 COLGATE BSPW PASTE 6 OZ 3PK SKU 902143 CREST CMPLT SCOPE OUTLST PSTE 5.4OZ 2 PK SKU 902701 COLGATE TOTAL WHITENING TP 4.8 OZ SKU 902967 CREST 3D WHITE BRILLIANCE CHARCOAL 3.9 OZ SKU 903463 COLGATE BSPW GEL FROSTY MINT 6 OZ SKU 905026 ARM & HAMMER COMPLETE CARE BKS PRX TP 6 OZ SKU 905028 COLGATE BSPW PASTE BRISK MINT 2.5 OZ SKU 905703 COLGATE BSPW PASTE BRISK MINT 6 OZ SKU 907121 CREST BS N PX WHTE TUBE FRESH MINT 5.7 OZ SKU 907125 COLGATE SPARKLING WHITE MINT ZING 2.5 OZ SKU 907151 ARM & HAMMERADV WHITE TP 4.3 FL OZ SKU 907766 COLGATE MAX FRESH COOL MINT TP 6 OZ SKU 907839 CREST COMPLETE SCOPE OUTLAST TP 5.4 OZ SKU 907872 COLG MAX FRESH COOL MINT TP 6.3 OZ 3PK SKU 998200 COLGATE OW STAIN FIGHTR TOOTHPASTE 4.2 OZ SKU 998278 COLGATE MAX FRESH WHTNING CHRCOAL TP 6 OZ SKU 998881 COLGATE CHARCOAL TP 2.2 OZ SKU 998902 CREST 3D WHITE STAIN ERASER 3.1OZ TWN PK SKU 999286 COLGATE ESSENTIALS CHARCOAL PASTE 4.6 OZ SKU 999318 COLGATE TOTAL CLEANMINT TOOTHPASTE 4.8 OZ SKU 999498 COLGATE OW STAINFIGHTERCLEANMNT4.2OZ 2PK SKU 999633 COLGATE OW STAIN FIGHTER CLEAN MNT 4.2 OZ SKU 999750 COLGATE DEEP CLEAN GEL TOOTHPASTE 2.5 OZ SKU 999916 CREST TARTAR PROTECTION PASTE 5.7 OZ SKU 900353 COLGATE TOTAL WHITENING GEL 4.8OZ 2 PK SKU 903152 CREST CAVITY PROTECTION PASTE 5.7 OZ SKU 907327 CREST PRO HEALTH WHITENING GEL TP 4.6 OZ SKU 999760 AIM CAVITY PRTCT MINT GEL 4.5 OZ SKU 999910 CREST 3D WHITE RADIANT MINT 2.7 OZ SKU 907160 CR FRESH WHT PEP GIM 2.4 OZ SKU 900791 COLGATE SENSITIVE WHITENING PASTE 6 OZ SKU 901677 COLGATE TRIPLE ACTION 2.5 OZ SKU 907170 COLGATE OW STAIN PREVENTION TP 2.1 OZ SKU 998277 CREST 3D WHITE CHARCOAL 2.7 OZ SKU 999282 ARM & HAMMER PEROXICARE MINT PASTE 6 OZ SKU 999937 CREST ANTI CAVITY PASTE 2.4 OZ SKU 907165 CLOSE UP CINN RED GEL TP 4 OZ SKU 907220 COLGATE BSPW GEL TP 6OZ 3PK; SKU 902966 COLGATE TOTAL WHTN GEL TP 4.8 OZ SKU 906406 COLGATE CAVITY PROTECTION 6 OZ SKU 907329 COLGATE MAX FRSH ADV WHTN CLN MNT TP 6 OZ SKU 998257 CG OW SF MINT PASTE 2.0 OZ SKU 999723 COLGATE KIDS JUNIOR BUBBLE FRUIT 3.5 OZ SKU 900592 CREST BKING SDA PEROXIDE WHTNG TP 2.4 OZ SKU 907865 CREST KIDS SPRKL TPST 2.2 OZ SKU 901243 CREST 3D WHITE ARTIC FRESH 2.7 OZ SKU 905045 COLGATE RENEWAL GUM REVITALIZE TP 3 OZ SKU 998741 ULTRA BRITE ADV WHITENING TP 6 OZ SKU 902134 COLGATE BASE DEEP CLEAN GEL 6 OZ SKU 900728 COLGATE TOTAL WHTN PASTE TP 4.8OZ 2PK SKU 901784 SENSODYNE PRO NAMELGENTLE WHT 2.7 OZ SKU 902124 SWAN ULTRA CLEAN ARCTIC MINT 33.8 FL OZ SKU 902840 CREST 3DW ULTRA WHITE 3 OZ SKU 903453 COLGATE KIDS TP ASRTD CHARACTERS 4.6 OZ SKU 905517 PEPSODENT ORIGINAL TP 4.5 OZ SKU 907136 SENSODYNE EXTRA WHTEN TP 2.7 OZ SKU 907781 CREST PSTE DNSIFY DAILY WHITENING 4.1 OZ SKU 998268 ORAJEL PP FLUORIDE TOOTHPASTE 4.2 OZ SKU 998397 CREST 3D WHITE BRILLIANCE THPASTE 2.7 OZ SKU 998730 TOM'S KIDS STRAWBERRY ANTICAVITY 5.1 OZ SKU 999099 CREST 3D WHITE STNERSR ICY CLN MNT 3.1 OZ SKU 999285 SENSODYNE COMPLETE FRESH PASTE 3.4 OZ SKU 902363 CREST PRO HEALTH DEEP CLEAN TP 3.5 OZ SKU 903245 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1458-2022 | 06-23-2022 | HYLANDS 4KIDS COLD N MUCUS RELIEF 4 FL OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1393-2022 | 06-23-2022 | READY IN CASESLEEP AID SOFT GEL 32 CT SKU 901457 READY IN CASE SLEEP AID 64 CT SKU 999026 ZZZQUIL WARMING BERRY 12FL OZ SKU 999811 GOOD SENSESLEEP AID CAPLET 100 CT SKU 901496 GOOD SENSESLEEP AID CAPLET 24 CT SKU 913985 GOOD SENSE EZ NITE SLEEP BERRY 12FL OZSKU 999789 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1424-2022 | 06-23-2022 | FW ASPIRIN CHEWABLE TABLET 36CT SKU 913990 GS ENTERIC ASPIRIN TABLET 120 CT SKU 913724 BAYER BACK BODY EX STRGTH CAPLETS 24CT SKU 900438 BAYER LOW DOSE 81 MG TABLET 120 CT SKU 916070 BAYER ASPIRIN 325MG TABLET 24CT SKU 913996 BAYER LOW DOSE TABLET 32CT SKU 915641 BAYER 81MG CHEWABLE TABLET 36 CT SKU 916078 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1378-2022 | 06-23-2022 | DISNEY LICENSED ANTI BAC WIPES 20 CT SKU 998908; ANTIBACTERIAL WIPES 40CT SKU 2007538 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1440-2022 | 06-23-2022 | NPX ENEMA 4.5 FL OZ 2 PK distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1376-2022 | 06-23-2022 | ALEVE ANALGESIC BACK MUSCLE 24 CT SKU 999787 ALEVE PM CAPLETS 20 CT SKU 900442 ALEVE CAPLET 50 CT SKU 916980 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1456-2022 | 06-23-2022 | REFENESEN MUCUS RELIEF TABLET 30 CT SKU 917531 MUCINEX DM MAX STRENGTH 7CT SKU 900854 RIC MUCUS RLF DM MAX STNGTH CHRY 6FL OZ SKU 999559 VICKS JARABE COUGH CONGESTION 8FLOZ SKU 998933 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-1379-2022 | 06-23-2022 | DOCTOR DANDRUF 2N1 SHAMP CLN APL 13.5FLOZ SKU 2005726 SUAVE 2N1 MENS CC ANTI DNDRF SHMP 28 FLOZSKU 2006512 MANE N TAIL 2 IN 1 ANTI DANDRUFF 12 FL OZ SKU 2024652 HEAD AND SOULDERS 2N1 SMOOTH SILKY 12.8 FL OZ SKU 2097272 DOCTOR MED DANDRUFF TREAT 11 FL OZ SKU 2005531 HEAD AND SOULDERS CLASSIC CLEAN SH 13.5 OZ SKU 2099110 DOCTOR DANDRUF 2IN1 SHAM DRYSCLP 13.5FL OZ SKU 2038805 HEAD AND SOULDERS 2IN 1 DRY SCALP 13.5 FL OZ SKU 2038366 HEAD AND SOULDERS 2IN 1 DRY SCALP SHAMPOO 23.7 FLOZ SKU 2005504 DOCTOR DANDRUFF 2N1 SHAMPOO 13.5FL OZ SKU 2038806 DOCTOR SHAMPOO T GEL 8.5 FL OZ SKU 2038935 DOCTOR 2N1 DANDRUFF CLSC 23.7FLOZ SKU 2005121 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-0004-2023 | 06-21-2022 | Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-734-90. Package NDCs: 63304-734-90; 63304-734-30; 63304-734-10; 63304-735-90; 63304-735-30; 63304-735-10 | Superpotent Drug: Out of specification for assay at the 12-month timepoint. | SUN PHARMACEUTICAL INDUSTRIES INC / 5712 bottles | Class III | Terminated |
| D-0005-2023 | 06-21-2022 | Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-735-90. Package NDCs: 63304-734-90; 63304-734-30; 63304-734-10; 63304-735-90; 63304-735-30; 63304-735-10 | Superpotent Drug: Out of specification for assay at the 12-month timepoint. | SUN PHARMACEUTICAL INDUSTRIES INC / 8640 bottles | Class III | Terminated |
| D-1190-2022 | 06-21-2022 | Testosterone Cypionate Injection, USP, 200mg/mL, CIII, Rx only, 1mL Single-dose vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Industries Ltd., Halol- Baroda Highway, Halol-Baroda, Highway, Halol- 389 350, Gujarat, India, NDC 62756-015-40. Package NDCs: 62756-017-40; 62756-015-40; 62756-016-40 | cGMP - Water leakage | SUN PHARMACEUTICAL INDUSTRIES INC / 50860 vials | Class II | Terminated |
| D-1188-2022 | 06-17-2022 | Morphine Sulfate extended-Release Tablets, USP; 60 mg, 100-count bottles, Rx only, manufactured by: Ohm Laboratories Inc., NJ; Relabeled by: Bryant Ranch Prepack, Inc, CA, NDC 63629-1089-01 | Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets. | Bryant Ranch Prepack, Inc. / | Class I | Terminated |
| D-1187-2022 | 06-17-2022 | Morphine Sulfate extended-Release Tablets, USP; 30 mg, 100-count bottles, Rx only, manufactured by: Ohm Laboratories Inc., New Brunswick NJ 08901 USA; Relabeled by: Bryant Ranch Prepack, Inc., Burbank, CA, 91504 USA, NDC: 63629-1088-01. | Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets. | Bryant Ranch Prepack, Inc. / | Class I | Terminated |
| D-1173-2022 | 06-16-2022 | Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC 68462-385-37), b) 60 ml-bottle (NDC 68462-385-02), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Baddi Himachal Pradesh 173205, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah NJ 07430. Package NDCs: 68462-385-37; 68462-385-02 | Defective Container | Glenmark Pharmaceuticals Inc., USA / 98, 307 packs | Class III | Terminated |
| D-1174-2022 | 06-16-2022 | Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA, NDC 33342-299-07 Package NDCs: 33342-299-07; 33342-299-11; 33342-299-44; 33342-299-12; 33342-300-11; 33342-300-44; 33342-300-12; 33342-301-11; 33342-301-44; 33342-301-12 | Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles. | Macleods Pharma Usa Inc / 168690 Tablets | Class II | Terminated |
| D-1189-2022 | 06-16-2022 | Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) 2.5 mg per vial, 30 glass vials per carton, Rx Only, Manufactured for Jubilant Draximage Inc. Kirkland, Canada, NDC 65174-270-30. Package NDCs: 65174-270-30 | Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing. | Jubilant Draximage Inc / 519 cartons/30 vials each | Class II | Terminated |
| D-1151-2022 | 06-15-2022 | 70% ISOPROPYL ALCOHOL First aid antiseptic, 4 FL OZ (118 mL) bottle, Made in US with US and foreign components for Medline Industries, Inc., Mundelein, IL 60060 USA, NDC: 53329-798-04, UPC (01) 10888277362291. Package NDCs: 53329-798-03; 53329-798-04; 53329-798-23; 53329-798-25; 1088827736 | Defective Container: Product may leak when squeezed or when not in an upright position determined to be due to defects in the bottle neck finish and insufficient tightening. | Vi-Jon, LLC / 3,157,620 bottles | Class II | Terminated |
| D-1156-2022 | 06-14-2022 | Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02. | Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution. | Teva Pharmaceuticals USA Inc / 4941 bottles | Class II | Terminated |
| D-1172-2022 | 06-13-2022 | Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber glass bottle, Rx only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC 50383-700-16 | Defective container: defect prevents product from dispensing as intended. | Akorn, Inc. / 44,400 bottles | Class II | Terminated |
| D-1175-2022 | 06-13-2022 | CVS Health Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 FL OZ (296 mL), Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 30594 2. | Microbial Contamination of a Non-Sterile Products: Testing of product onfirmed the presence of Gluconacetobacter Liquefaciens | Vi-Jon, LLC / 98,958 bottles | Class I | Terminated |
| D-1184-2022 | 06-10-2022 | Boric Acid 600 mg per suppository, 14 Vaginal Suppositories per box, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085 | Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection | Wedgewood Village Pharmacy, LLC / 14 suppositories | Class II | Terminated |
| D-1185-2022 | 06-10-2022 | Estriol 1mg/gm, Vaginal Cream, 30 gm tube, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085 | Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection | Wedgewood Village Pharmacy, LLC / 1 tube | Class II | Terminated |
| D-1181-2022 | 06-10-2022 | Bethanechol Chloride 1mg/ml, 80 ml Suspension bottles Banana/Strawberry, Qty:1, Wedgewood Village Pharmacy LLC, 405 Heron Dr. Ste 200, Swedesboro, NJ 08085 | Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection | Wedgewood Village Pharmacy, LLC / 1 suspension bottle | Class II | Terminated |
| D-1186-2022 | 06-10-2022 | Estriol 1mg/gm, Vaginal Cream, 60 gm tube, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085 | Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection | Wedgewood Village Pharmacy, LLC / 9/18/2022 | Class II | Terminated |
| D-1284-2022 | 06-10-2022 | Arti King Refozado con Ortiga y Omega 3 Tablets, 100-count bottles, Hecho en Mexico por: "PLANTAS MEDICINALES DE MEXICO", Melchor Ocampo No. 55 Local D, Delegacion Xochimilco, C.P. 16800 Mexico, UPC 7 501031 111138 | Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and dexamethasone. | Latin Foods Market / unknown | Class I | Terminated |
| D-1182-2022 | 06-10-2022 | Doxycycline (as Calcium) (equivalent to 50mg/5mL), 10 mg/ml, 60 ml suspension bottles, Peppermint, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Dr, Ste 200, Swedesboro, NJ 08085 | Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection | Wedgewood Village Pharmacy, LLC / 24 bottles | Class II | Terminated |
| D-1183-2022 | 06-10-2022 | Boric Acid 600 mg capsules, 14 capsules per box, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085 | Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection | Wedgewood Village Pharmacy, LLC / 1 box | Class II | Terminated |
| D-1154-2022 | 06-10-2022 | Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40. Package NDCs: 62756-017-40; 62756-015-40; 62756-016-40 | Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion | SUN PHARMACEUTICAL INDUSTRIES INC / 47,500 vials | Class II | Terminated |
| D-1164-2022 | 06-10-2022 | Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC #33342-052-10 & NDC # 33342-052-44, Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Package NDCs: 33342-050-07; 33342-050-10; 33342-050-44; 33342-050-12; 33342-051-07; 33342-051-10; 33342-051-44; 33342-051-12; 33342-052-07; 33342-052-10; 33342-052-44; 33342-052-12 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Macleods Pharma Usa Inc / 84/1000 count bottles | Class II | Terminated |
| D-1170-2022 | 06-10-2022 | Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, 60 mL (2 fl. oz.) bottle, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, N.Y. 11701. NDC: 50383-732-02 | Defective Delivery System: Potential defect that could prevent the product from dispensing as intended. | Akorn, Inc. / 2,736 Bottles | Class II | Terminated |
| D-1150-2022 | 06-10-2022 | Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin Limited, Nagpur-441108, India, NDC 68180-169-16 | Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study. | Lupin Pharmaceuticals Inc. / 3,216 bottles | Class II | Terminated |
| D-1165-2022 | 06-09-2022 | SnoreStop NasoSpray, 0.3 FL OZ (9 mL), Green Pharmaceuticals Inc. Camarillo, CA 93012, NDC 61152-199-99, UPC 7 69682 29101 3 | Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain microbial contamination identified as Providencia rettgeri. | Green Pharmaceuticals, Inc. / 1074 spray bottles | Class I | Terminated |
| D-1152-2022 | 06-09-2022 | Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per Carton (51862-455-04), Rx only, Manufactured for: Mayne Pharma Greenville, NC 27834 Package NDCs: 51862-453-01; 51862-453-04; 51862-454-01; 51862-454-04; 51862-455-01; 51862-455-04 | Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint. | Mayne Pharma Inc / 1440 cartons | Class II | Terminated |
| D-1160-2022 | 06-08-2022 | Allergy Bee Gone for Kids Nasal Swab Remedy 0.33 FL OZ (10 mL) tubes, UPC Code 860002022116 | Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain elevated levels of yeast and mold as well as the presence of Bacillus cereus. | Buzzagogo, LLC / 28,328 tubes | Class I | Terminated |
| D-1489-2022 | 06-07-2022 | Diphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6741-72 | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC / 349,100 cups | Class II | Terminated |
| D-1487-2022 | 06-07-2022 | CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 4 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-7098-94 | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC / 49,280 cups | Class II | Terminated |
| D-1493-2022 | 06-07-2022 | CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04 FL.OZ (60mL), packaged in 12-5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-311-05 UPC 8 60003 67145 0 | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC / 1,464 ampoules | Class II | Terminated |
