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 October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
| D-1477-2022 | 06-07-2022 | MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 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 0904-6840-72. | Microbial Contamination of Non-Sterile Products. | Plastikon Healthcare LLC / 7,700 cups | Class I | Terminated |
| D-1484-2022 | 06-07-2022 | Acetaminophen Oral Solution 160 mg / 5 mL, 5 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 0904-6738-70 | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC / 290,270 cups | Class II | Terminated |
| D-1483-2022 | 06-07-2022 | Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 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 0904-6839-73 | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC / 88,500 cups | Class II | Terminated |
| D-1478-2022 | 06-07-2022 | Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 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 0904-6838-73 | Microbial Contamination of Non-Sterile Products. | Plastikon Healthcare LLC / 220,500 cups | Class I | Terminated |
| D-1494-2022 | 06-07-2022 | CORRECTDOSE Children's COUGH & CHEST CONGESTION DM (Guaifenesin 100 mg / Dextromethorphan 5 mg per 5 mL) 2.04FL. OZ (60mL), packaged in 12-5 individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-321-05 UPC 8 60003 67146 7 | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC / 1,464 ampoules | Class II | Terminated |
| D-1492-2022 | 06-07-2022 | CORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL), 2.04 FL. OZ (60 mL) packaged in 12- 5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-302-05 UPC 8 60003 67144 3 | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC / 7,200 ampoules | Class II | Terminated |
| D-1480-2022 | 06-07-2022 | MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 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 0904-6846-73. | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC / 502,600 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-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-1490-2022 | 06-07-2022 | GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL, 5 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 0904-6844-70 | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC / 280,500 cups | Class II | Terminated |
| D-1486-2022 | 06-07-2022 | Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 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 0904-6820-76 | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC / 3,507,740 cups | Class II | Terminated |
| D-1491-2022 | 06-07-2022 | GUAIFENESIN AND DEXTROMETHORPHAN 200-20 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 0904-6980-72 | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC / 246,200 cups | Class II | Terminated |
| D-1476-2022 | 06-07-2022 | MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 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 0904-6846-73. | Microbial Contamination of Non-Sterile Products | Plastikon Healthcare LLC / 24,400 cups | Class I | Terminated |
| D-1479-2022 | 06-07-2022 | Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 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 0904-6839-73 | Microbial Contamination of Non-Sterile Products. | Plastikon Healthcare LLC / 43,200 cups | Class I | Terminated |
| D-1481-2022 | 06-07-2022 | MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 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 0904-6840-72. | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC / 92,200 cups | Class II | Terminated |
| D-1482-2022 | 06-07-2022 | Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 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 0904-6838-73 | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC / 521,700 cups | Class II | Terminated |
| D-1488-2022 | 06-07-2022 | Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 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 0904-6740-70 | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC / 217,700 cups | Class II | Terminated |
| D-1485-2022 | 06-07-2022 | Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 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 0904-6739-71 | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC / 848,500 cups | Class II | Terminated |
| D-1161-2022 | 06-06-2022 | Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-163-90 UPC 3 72789 16390 1 Package NDCs: 72789-163-90; 72789-164-90; 72789-165-90 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | PD-Rx Pharmaceuticals, Inc. / 1441 bottles | Class II | Terminated |
| D-1163-2022 | 06-06-2022 | Losartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-165-90 UPC 3 72789 16590 5 Package NDCs: 72789-163-90; 72789-164-90; 72789-165-90 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | PD-Rx Pharmaceuticals, Inc. / 1320 bottles | Class II | Terminated |
| D-1162-2022 | 06-06-2022 | Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-164-90 UPC 3 72789 16490 8 Package NDCs: 72789-163-90; 72789-164-90; 72789-165-90 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | PD-Rx Pharmaceuticals, Inc. / 687 bottles | Class II | Terminated |
| D-1176-2022 | 06-03-2022 | Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose vial, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals 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 | CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery. | SUN PHARMACEUTICAL INDUSTRIES INC / 27 vials | Class II | Terminated |
| D-1155-2022 | 06-03-2022 | Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, Mfd. by: Sun Pharmaceutical Industries Ltd. Mumbai, India, Dist. by: Sun Pharmaceutical Industries In., Cranbury, NJ 08512, NDC 57664-783-68, packaged in bottles. | Failed Tablet/Capsule Specification; oversized tablet found in a bottle | SUN PHARMACEUTICAL INDUSTRIES INC / 4608 bottles | Class II | Terminated |
| D-1153-2022 | 06-03-2022 | 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 | CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities. | SUN PHARMACEUTICAL INDUSTRIES INC / 97,450 vials | Class II | Terminated |
| D-1295-2022 | 05-26-2022 | Artri Ajo King Reforzado con Ortiga y Omega 3 tablets, 500 mg, 100-count bottle, Hecho en Mexico por: PLANTAS MEDICINALES DE MEXICO , Melchor Ocampo No. 55 Local D, Delegacion Xochimilco. C.P. 16800, Mexico, D.F., ASIN B092P4615M, UPC 7 501031 111190 | Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac. | Amazon.com, Inc. / 2,441 bottles | Class I | Terminated |
| D-1297-2022 | 05-26-2022 | Artri King Reforzado con Ortiga y Omega 3 tablets, 500 mg, 100-count bottle, Hecho en Mexico por: PLANTAS MEDICINALES DE MEXICO , Melchor Ocampo No. 55 Local D, Delegacion Xochimilco. C.P. 16800, Mexico, D.F., ASIN B084KSV12L, UPC 7 501031 111190 | Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac. | Amazon.com, Inc. / 15,087 bottles | Class I | Terminated |
| D-1296-2022 | 05-26-2022 | Ortiga mas Ajo Rey Reforzado con Omega 3, 6 y 9, is packaged in a carton containing 30 tablets (500 mg c/u) in a bottle and 60 capsules (400 mg c/u) in a bottle, Hecho en Mexico por: Omega Nutrition , Jorge Washington No. 108 Col. Las Americas, Hidalgo del Parral, Chihuahua. C.P. 33880, ASIN B084L2XM3Z, UPC 3166557819586 | Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac. | Amazon.com, Inc. / 35,622 cartons | Class I | Terminated |
| D-0987-2022 | 05-24-2022 | B-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HCl 2%, Niacinamide 2%, Thiamine HCl 2%, Chlorobutanol 0.5%, Riboflavin 0.05%, Chromic Chloride 0.003%), 30 mL Multi-Dose Vial, packaged in 2 x 30 mL Multi-Dose Vials per carton, US Specialty Formulations, LLC, 116 Research Drive, Bethlehem, PA 18015, P/N: 234-15523 | Lack of Assurance of Sterility | US Specialty Formulations LLC / 1992 vials | Class II | Terminated |
| D-0986-2022 | 05-24-2022 | Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allentown, PA 18103, PN: 69389-06229 | Lack of Assurance of Sterility | US Specialty Formulations LLC / 781 vials | Class II | Terminated |
| D-0991-2022 | 05-24-2022 | Earache Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-3233-15 Package NDCs: 0363-3233-15 | Microbial contamination of non-sterile product. | Grato Holdings, Inc. / 31,872 bottles | Class II | Terminated |
| D-0989-2022 | 05-24-2022 | Homeopathic EarAche Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: RITE AID, 30 Hunter Lane, Camp Hill, PA 17011. NDC 11822-3644-3 Package NDCs: 11822-3644-3 | Microbial contamination of non-sterile product. | Grato Holdings, Inc. / 16,374 bottles | Class II | Terminated |
| D-1157-2022 | 05-24-2022 | Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, 100-count bottles, Melchor Ocampo No. 55 Local D, Delegacion Xochimilco, C.P. 16800, Mexico, D.F., UPC 7 501031 111190. | Marketed Without An Unapproved NDA/ANDA: Product lot found to be tainted with undeclared diclofenac, an FDA approved nonsteroidal anti-inflammatory drug (NSAID) for the treatment of pain and inflammation. | Walmart Inc / 1308 bottles total | Class I | Completed |
| D-1159-2022 | 05-24-2022 | Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, a) 100-count bottles labeled with UPC 7 501031 111190 and UPC 6 09002 40885, and b) 2 pack of 100-count bottles per carton UPC 3 72426 01434 | Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims. | Walmart Inc / 1308 bottles total | Class II | Completed |
| D-0990-2022 | 05-24-2022 | Homeopathic EarAche Ear Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 59779-568-15 | Microbial contamination of non-sterile product. | Grato Holdings, Inc. / 50,640 bottles | Class II | Terminated |
| D-1158-2022 | 05-24-2022 | Artri Ajo King Reforzado con Ortiga y Omega 3 Tablets, ORIGINAL, 100-count bottles, UPC 7 501031 12705. | Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims. | Walmart Inc / 1308 bottles total | Class II | Completed |
| D-1166-2022 | 05-23-2022 | Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Subcutaneous Use, 4 prefilled syringes, each containing 284 mg of inotersen, (equivalent to 300 mg inotersen sodium in 1.5 ml of solution), Distributed by Sobi, Inc. Inc Waltham MA 02451, NDC: 72126-007-01 | Superpotent: High Out of specification (OOS) test result for percent label claim (%LC). | Akcea Therapeutics, Inc. / 450 cartons | Class I | Terminated |
| D-0973-2022 | 05-18-2022 | Losartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-934-05 1000 film coated tablets NDC 64380-934-08 Package NDCs: 64380-933-04; 64380-933-05; 64380-933-08; 64380-934-04; 64380-934-05; 64380-934-08; 64380-935-04; 64380-935-05; 64380-935-08 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Strides Pharma Inc. / 381456 bottles | Class II | Terminated |
| D-0972-2022 | 05-18-2022 | Losartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-933-05 1000 film coated tablets NDC 64380-933-08 Package NDCs: 64380-933-04; 64380-933-05; 64380-933-08; 64380-934-04; 64380-934-05; 64380-934-08; 64380-935-04; 64380-935-05; 64380-935-08 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Strides Pharma Inc. / 200407 bottles | Class II | Terminated |
| D-0974-2022 | 05-18-2022 | Losartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-935-05 1000 film coated tablets NDC 64380-935-08 Package NDCs: 64380-933-04; 64380-933-05; 64380-933-08; 64380-934-04; 64380-934-05; 64380-934-08; 64380-935-04; 64380-935-05; 64380-935-08 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Strides Pharma Inc. / 96966 bottles | Class II | Terminated |
| D-0967-2022 | 05-18-2022 | Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-957-10 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 585660 syringes | Class II | Terminated |
| D-0955-2022 | 05-18-2022 | Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-05 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 32,550 syringes | Class II | Terminated |
| D-0961-2022 | 05-18-2022 | Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), Preservative Free, 4 mL Pre-Filled Syringe, 5 x 4 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-946-04 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 115640 syringes | Class II | Terminated |
| D-0953-2022 | 05-18-2022 | Epinephrine Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-925-10 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 134415 syringes | Class II | Terminated |
| D-0959-2022 | 05-18-2022 | Ketamine Hydrochloride Injection, USP, 30 mg/3 mL (10 mg/mL), 3 mL Pre-Filled Syringe, 5 x 3 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-33 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 30,290 syringes | Class II | Terminated |
| D-0965-2022 | 05-18-2022 | Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-955-10 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 57810 syringes | Class II | Terminated |
| D-0951-2022 | 05-18-2022 | Calcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL, 1 g/10 mL (100 mg/mL), 10 mL Pre-Filled Syringe, 5 x 10 Pre-filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-950-10 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 30180 syringes | Class II | Terminated |
| D-0962-2022 | 05-18-2022 | Lidocaine HCl Injection, USP, 2%, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-FIlled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-949-05 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 65590 syringes | Class II | Terminated |
| D-0969-2022 | 05-18-2022 | Succinylcholine Chloride Injection, USP, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-920-05 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 181560 syringes | Class II | Terminated |
| D-0950-2022 | 05-18-2022 | 8.4% Sodium Bicarbonate Injection, USP, 1 mEq/mL, 4.2 g/50 mL (84 mg/mL), 1 x 50 mL Pre-Filled Syringe, packaged in a) 10 x 1 syringe carton, b) 30 x 1 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-214-50 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 13612 syringes | Class II | Terminated |
| D-0954-2022 | 05-18-2022 | Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL), 150 mL IV Bag, 10 x 1 IV Bag, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-523-21 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 3532 bags | Class II | Terminated |
| D-0957-2022 | 05-18-2022 | Hydromorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL), 50 mL Pre-Filled Syringe, 5 x 50 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-559-50 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 2795 syringes | Class II | Terminated |
| D-0966-2022 | 05-18-2022 | Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Pre-Filled Syringes, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-956-10 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 76860 syringes | Class II | Terminated |
| D-0964-2022 | 05-18-2022 | Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP, 500 mL Single-Dose Container Bag, 10 x 1 IV Bag, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-543-50 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 3587 bags | Class II | Terminated |
| D-0963-2022 | 05-18-2022 | Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-902-05 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 64450 syringes | Class II | Terminated |
| D-0956-2022 | 05-18-2022 | Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL), Preservative Free, 3 mL Pre-Filled Syringe, 5 x 3 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-03 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 6150 syringes | Class II | Terminated |
| D-0958-2022 | 05-18-2022 | Hydromorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL), 30 mL Pre-Filled Syringe, 5 x 30 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-529-30 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 6210 syringes | Class II | Terminated |
| D-0960-2022 | 05-18-2022 | Ketamine Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-55 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 107530 syringes | Class II | Terminated |
| D-0952-2022 | 05-18-2022 | EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-544-10 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 35850 syringes | Class II | Terminated |
| D-0968-2022 | 05-18-2022 | Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-924-05 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 604080 syringes | Class II | Terminated |
| D-0988-2022 | 05-18-2022 | Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only, Carton NDC 0703-1501-02, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Vial NDC 0703-1501-01 | Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing | Teva Pharmaceuticals USA Inc / 3109 cartons | Class III | Terminated |
