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 08, 2025 and include a total of 16999 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0205-2021 | 12-17-2020 | PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride (80 mcg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081612 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 7,890 syringes | Class II | Terminated |
| D-0200-2021 | 12-17-2020 | Lidocaine HCl 2% 5 mL, 20 mg/mL, Rx Only, 5 mL syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072309 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 7,275 syringes | Class II | Terminated |
| D-0195-2021 | 12-17-2020 | HYDROmorphone HCl 6 mg/30mL in 0.9% Sodium Chloride Injection (0.2 mg/mL), Rx Only, a) 30 mL Plungerless Single Dose Syringe (barcode 70004030016) and b) 30 mL Single Dose Syringe (barcode 70004030018), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 3,092 syringes | Class II | Terminated |
| D-0189-2021 | 12-17-2020 | ePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection, 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004060412 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 7,257 syringes | Class II | Terminated |
| D-0201-2021 | 12-17-2020 | Morphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride (1mg/mL) CII, Rx Only, 3 ml Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010025 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 751 syringes | Class III | Terminated |
| D-0210-2021 | 12-17-2020 | PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride (100 mcg/mL), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081011 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 14,580 syringes | Class II | Terminated |
| D-0213-2021 | 12-17-2020 | ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals 8521 Knoedl Ct., Little Rock, AR, 72205, barcode 70004060409 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 9416 syringes | Class II | Terminated |
| D-0207-2021 | 12-17-2020 | Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL), Rx only, 3 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090025 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 5,990 syringes | Class II | Terminated |
| D-0209-2021 | 12-17-2020 | Morphine Sulfate 30 mg/30 mL in 0.9% Sodium Chloride (1mg/ml), CII, Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010016 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 116 syringes | Class II | Terminated |
| D-0202-2021 | 12-17-2020 | morphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection, (5 mg/mL), Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010316 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 50 syringes | Class II | Terminated |
| D-0197-2021 | 12-17-2020 | Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043012 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 11,075 syringes | Class II | Terminated |
| D-0223-2021 | 12-16-2020 | Succinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes, Rx only, US Compounding, 1270 Don's Lane, Conway, AR 72032 | Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in the incorrect position on the product label making it illegible. | US Compounding Inc / 1534 syringes | Class III | Terminated |
| D-0171-2021 | 12-14-2020 | Vasopressin 20 Units added to 0.9% Sodium Chloride 100 mL Rx Only, Single Dose Container, SCA Pharmaceuticals 8821 Knoedl Ct. Little Rock, AR 72205 Bar Code 70004093232 | Subpotent drug. | SCA Pharmaceuticals, Inc. / 654 bags | Class II | Terminated |
| D-0165-2021 | 12-14-2020 | Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa Medicare Limited Jadcherla -509301 INDIA Distributed by: Cipla USA, Inc. 10 Independence Blvd, Suite 300 Warren, NJ 07059 NDC 69097-805-40 Package NDCs: 69097-805-40 | cGMP deviations: Vials may not be sealed correctly affecting sterility. | CIPLA / 2151 vials | Class II | Terminated |
| D-0172-2021 | 12-10-2020 | Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dose Vial (NDC 63323-462-01), packaged as 25 Single Dose Vials per tray (NDC 63323-462-37), Rx only, Fresenius Kabi, Lake Zurich, IL 60047. Package NDCs: 63323-465-01; 63323-465-57; 63323-467-01; 63323-467-57; 63323-460-01; 63323-460-37; 63323-464-02; 63323-464-37; 63323-464-03; 63323-464-31; 63323-466-01; 63323-466-37; 63323-466-02; 63323-466-31; 63323-462-04; 63323-462-17; 63323-462-01; 63323-462-37; 63323-462-02; 63323-462-31 | Subpotent Drug: Low out-of-specification assay results for the epinephrine component. | Fresenius Kabi USA, LLC / 4411 trays | Class II | Terminated |
| D-0170-2021 | 12-09-2020 | Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., One Marina Park Drive, 12th Floor, Boston, MA 02210, NDC 59922-631-01 Package NDCs: 59922-631-01 | CGMP Deviations | Akebia Therapeutics dba Keryx Biopharmaceutials, Inc / 2,170 bottles | Class II | Terminated |
| D-0148-2021 | 12-09-2020 | Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count bottle, b)120-count bottle, Rx only, Manufactured for: Biogen Inc., Cambridge, MA 02142, NDC 64406-020-01 Package NDCs: 64406-020-01; 64406-020-03; 64406-020-05; 64406-020-07 | Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing. | Biogen MA Inc. / 5,307 bottles | Class II | Terminated |
| D-0174-2021 | 12-09-2020 | Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC 60432-150-04, b) 1 pint (473 mL), NDC 60432-150-16, Rx Only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053 | Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities. | Morton Grove Pharmaceuticals, Inc. / 127,392 bottles | Class II | Terminated |
| D-0121-2021 | 12-08-2020 | Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before use, Single Dose Vial, Sterile, Cytotoxic Agent, Rx Only, 10 mL vial, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, Vial NDC 72485-210-01, Carton NDC 72485-210-08. Package NDCs: 72485-210-01; 72485-210-08 | CGMP Deviations | Shilpa Medicare Limited / 2,064 vials | Class II | Terminated |
| D-0125-2021 | 12-08-2020 | Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-203-30. Package NDCs: 72485-203-30 | CGMP Deviations | Shilpa Medicare Limited / 4166 bottles | Class II | Terminated |
| D-0124-2021 | 12-08-2020 | Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-202-90. Package NDCs: 72485-202-90 | CGMP Deviations | Shilpa Medicare Limited / 2611 bottles | Class II | Terminated |
| D-0122-2021 | 12-08-2020 | Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, Jadcherla, 509301, India, Distributed by: Armas Pharmaceuticals, Inc. Manalapan, NJ 07726 NDC 72485-201-01. Package NDCs: 72485-201-01 | CGMP Deviations | Shilpa Medicare Limited / 35,931 vials | Class II | Terminated |
| D-0126-2021 | 12-08-2020 | Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only, Rx Only, 8 mL Single Use Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, NDC 72485-216-08. Package NDCs: 72485-216-08 | CGMP Deviations | Shilpa Medicare Limited / 2008 vials | Class II | Terminated |
| D-0123-2021 | 12-08-2020 | Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, NDC 72606-558-01. | CGMP Deviations | Shilpa Medicare Limited / 6,560 vials | Class II | Terminated |
| D-0167-2021 | 12-07-2020 | Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01. | Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility. | AVKARE Inc. / 38715 bottles | Class II | Terminated |
| D-0168-2021 | 12-07-2020 | TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10 | Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility. | AVKARE Inc. / 14368 bottles | Class I | Terminated |
| D-0169-2021 | 12-07-2020 | Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, Vial NDC 0641-0497-17 Package NDCs: 0641-0497-17; 0641-0497-25; 0641-6144-01; 0641-6144-25 | Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial. | Hikma Pharmaceuticals USA Inc. / 1,324,072 vials | Class II | Terminated |
| D-0146-2021 | 12-03-2020 | Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablets (10 x 10 unit-dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 NDC 68382-772-77 Package NDCs: 68382-771-30; 68382-771-77; 68382-772-30; 68382-772-77 | Failed Dissolution Specifications | Zydus Pharmaceuticals (USA) Inc / 22,848 cartons | Class II | Terminated |
| D-0145-2021 | 12-03-2020 | Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 NDC 68382-771-77 Package NDCs: 68382-771-30; 68382-771-77; 68382-772-30; 68382-772-77 | Failed Dissolution Specifications | Zydus Pharmaceuticals (USA) Inc / 15,144 cartons | Class II | Terminated |
| D-0229-2021 | 12-01-2020 | Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl. Oz. (250 mL) Bottle, Distributed by: Universal Distributors LLC, 6197 S. Rural Rd.,Tempe AZ, 85283, Made in Mexico by: Gaza Proveedora De Servicios De Hospedaje y Alimentos S.A. de C.V., UPC 8 64972 00049 5, NDC 76540-100-02 | cGMP deviations: Product made at the same facility where product tested was sub-potent. | GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION / 26,000 liters | Class II | Ongoing |
| D-0230-2021 | 12-01-2020 | Zapien Productos Hand Sanitizer Gel Antibacterial, 33.8 FL. OZ (1000 mL), Made by GAZA S.A. DE C.V. Castilla St. #1473-A ZIP 45410 Tonala, Jalisco, Mexico, UPC: 7 501700 623504, NDC numbers: 76938-001-01, 76938-001-02, 76938-001-03. | cGMP deviations: Product made at the same facility where product tested was sub-potent. | GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION / 43875 liters | Class II | Ongoing |
| D-0130-2021 | 11-30-2020 | PT-141, 10 MG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Advanced Nutriceuticals, LLC / 1 vial | Class II | Ongoing |
| D-0133-2021 | 11-30-2020 | THYMOSIN ALPHA, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Advanced Nutriceuticals, LLC / 4 vials | Class II | Ongoing |
| D-0139-2021 | 11-30-2020 | CEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Advanced Nutriceuticals, LLC / 1 vial | Class II | Ongoing |
| D-0136-2021 | 11-30-2020 | NANDROLONE, 200 MCG/ML, 2 ML, The Guyer Institute of Molecular Medicine, Indianapolis, IN | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Advanced Nutriceuticals, LLC / 2 vials | Class II | Ongoing |
| D-0143-2021 | 11-30-2020 | LL-37, 2000 MCG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Advanced Nutriceuticals, LLC / 1 vial | Class II | Ongoing |
| D-0137-2021 | 11-30-2020 | B12 for Injection, 2 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Advanced Nutriceuticals, LLC / 1 vials | Class II | Ongoing |
| D-0129-2021 | 11-30-2020 | FGL, 10 MG/ML, 3 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Advanced Nutriceuticals, LLC / 1 vial | Class II | Ongoing |
| D-0135-2021 | 11-30-2020 | GHRP, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Advanced Nutriceuticals, LLC / 1 vial | Class II | Ongoing |
| D-0131-2021 | 11-30-2020 | AOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Institute of Molecular Medicine, Indianapolis, IN | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Advanced Nutriceuticals, LLC / 3 vials | Class II | Ongoing |
| D-0142-2021 | 11-30-2020 | HIGH DOSE B12, 10 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Advanced Nutriceuticals, LLC / 1 vials | Class II | Ongoing |
| D-0144-2021 | 11-30-2020 | Pentosan Polysulfate, 300 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Advanced Nutriceuticals, LLC / 1 vial | Class II | Ongoing |
| D-0138-2021 | 11-30-2020 | DSIP, 1000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Advanced Nutriceuticals, LLC / 1 vial | Class II | Ongoing |
| D-0128-2021 | 11-30-2020 | CJC-1295, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Advanced Nutriceuticals, LLC / 6 vials | Class II | Ongoing |
| D-0141-2021 | 11-30-2020 | GHK-CU, 10 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Advanced Nutriceuticals, LLC / 1 vial | Class II | Ongoing |
| D-0132-2021 | 11-30-2020 | BPC-157, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Advanced Nutriceuticals, LLC / 4 vials | Class II | Ongoing |
| D-0140-2021 | 11-30-2020 | THYMOSIN BETA - 4, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Advanced Nutriceuticals, LLC / 3 vials | Class II | Ongoing |
| D-0134-2021 | 11-30-2020 | IPAMORELIN, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Advanced Nutriceuticals, LLC / 3 vials | Class II | Ongoing |
| D-0164-2021 | 11-25-2020 | Lavar 70 Gel Hand Sanitizer 70% Alcohol Content, 33.8 FL OZ (1L), Distributed By Blue Ridge Southern Supply, LLC. 1130 Aba St. Blue Ridge, GA 30513 Produced By: Simex Logistics S.A. de C.V Salvatierra No. 101 Fraccionamiento El Puente Celaya, Guanajuato, Mexico, Barcode: 7 05333 5897 | Subpotent drug | Simex Logistics SA de CV / 38016 bottles | Class II | Terminated |
| D-0161-2021 | 11-25-2020 | CitruGel Hand Sanitizer Advanced Formula 70% Alcohol Fresh Lemon Scent, 33.81 FL OZ (1L), Distributed By Citru Gel Inc. Henderson, NV 89052 www.citrugel.com NDC: 78247-002-01 | Subpotent drug | Simex Logistics SA de CV / 1800 bottles | Class II | Terminated |
| D-0163-2021 | 11-25-2020 | UVT World Gel Hand Sanitizer 70% Alcohol Content, 33.9 FL OZ (1LT), Distributed By UVT World Newport Beach, CA 92660 www.uvt.world Produced By: Simex Logistics S.A. de C.V. Salvatierra No. 101 Fraccionamiento El Puente Celaya, Guanajuato, Mexico Barcode: 7 00306 88677 2 | Subpotent drug | Simex Logistics SA de CV / 16308 bottles | Class II | Terminated |
| D-0175-2021 | 11-25-2020 | Neostigmine Methylsulfate PF Inj. 5 mg/5 mL, 5 mL Single Use Syringes, Hospital/Office Use Only. US Compounding 1270 Don's Lane Conway, AR 72032 (800) 718-3588 NDC 62295-3324-05 | Labelling: Missing label. | US Compounding Inc / 1640 syringes | Class III | Terminated |
| D-0160-2021 | 11-25-2020 | +Protec Hands Antibacterial Gel Topical Solution Instant Sanitizer Hands 70% Alcohol Antiseptic, packaged in bottles of a) 33.8 Oz (1000mL) Barcode: GOOD-GEL-04062020L; b) 127.8 oz (3780mL) Barcode 0723707893163, Distributed by: PS Promotional Services LLC Allen Street #406 Dallas, Texas 75204 Produced By: Simex Logistics S.A. de C.V. Salvatierra No. 101 Fraccionamiento El Puente. Celaya, Guanajuato, Mexico. | Subpotent drug | Simex Logistics SA de CV / 19340 bottles | Class II | Terminated |
| D-0162-2021 | 11-25-2020 | Health & Hand Gel Hand Sanitizer 70% Alcohol Content, 33.8 FL OZ (1L), Distributed By Blue Ridge Southern Supply, LLC 1130 Ada St. Blue Ridge, GA 30513 Produced By: Simex Logistics S.A. de C.V. Salvatierra No. 101 Fracc. El Puente C.P. 38040 Celaya, Guanajuato, Mexico. [email protected] Barcode: 6 18149 21988 9 | Subpotent drug | Simex Logistics SA de CV / 19008 bottles | Class II | Terminated |
| D-0166-2021 | 11-25-2020 | Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920 NDC 13668-462-01 Package NDCs: 13668-453-30; 13668-453-01; 13668-462-30; 13668-462-01 | Failed Dissolution Specifications | Torrent Pharma Inc / 2496 Bottles | Class I | Terminated |
| D-0173-2021 | 11-24-2020 | Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013, INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC: 67877-614-15. Package NDCs: 67877-613-15; 67877-613-05; 67877-614-15; 67877-614-05 | Failed Dissolution Specifications; Out of Specification (low) results were obtained. | Ascend Laboratories LLC / 1200 bottles | Class II | Terminated |
| D-0185-2021 | 11-23-2020 | Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, packaged as a) 100 ml (when mixed) bottle, NDC 67877-544-88; b) 200 ml (when mixed) bottle NDC 67877-544-68, Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA. Distributed by: Ascend Lab,oratories, LLC Parsippany, NJ 07054 Package NDCs: 67877-544-88; 67877-544-68; 67877-545-88; 67877-545-68 | Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL. | Ascend Laboratories LLC / 20,232 bottles | Class II | Terminated |
| D-0235-2021 | 11-20-2020 | HUMAN CHORIONIC GONADOTROPIN 6,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035 | CGMP deviations: Lack of potency testing. | Complete Pharmacy and Medical Solutions, LLC. / 2418 vials | Class II | Terminated |
| D-0234-2021 | 11-20-2020 | HUMAN CHORIONIC GONADOTROPIN 11,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035 | CGMP deviations: Lack of potency testing. | Complete Pharmacy and Medical Solutions, LLC. / 1182 vials | Class II | Terminated |
| D-0147-2021 | 11-20-2020 | Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205 | Subpotency: Out-of-specification stability test result for low potency was obtained. | SCA Pharmaceuticals / 4,843 syringes | Class III | Terminated |
| D-0237-2021 | 11-20-2020 | HUMAN CHORIONIC GONADOTROPIN 1,250 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035 | CGMP deviations: Lack of potency testing. | Complete Pharmacy and Medical Solutions, LLC. / 2400 vials | Class II | Terminated |
| D-0236-2021 | 11-20-2020 | HUMAN CHORIONIC GONADOTROPIN 5,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035 | CGMP deviations: Lack of potency testing. | Complete Pharmacy and Medical Solutions, LLC. / 1144 vials | Class II | Terminated |
| D-0127-2021 | 11-20-2020 | Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), packaged in cartons of 50 cartridges (1.7 mL each), Rx only, Manufactured for SEPTODONT, Inc., Louisville, CO 80027, by Novocol Pharmaceutical of Canada, Inc., Cambridge, ON N1R 6X3, Canada, NDC 0362-1098-90 Package NDCs: 0362-1098-90 | Labeling: Label mix-up | Novocol Pharmaceutical of Canada, Inc. / 15,398 cartridges | Class III | Terminated |
| D-0113-2021 | 11-19-2020 | CVS Health Hydrating Healing Ointment (Petrolatum 41%), Net Wt 3 OZ (85g), Distributed by CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 UPC 0 50428 53642 1 | Lack Of CGMP:s Low weight fill tubes were identified in one lot of CVS Healing Ointment. | US Pharmaceuticals Inc. / 3312 units | Class II | Terminated |
| D-0270-2021 | 11-19-2020 | Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 2 mL Single-Dose Vial, Rx Only, Distributed by: Areva Pharmaceuticals, Inc., Gerogetown, IN 47122, Made in India, NDC 59923-714-02. | CGMP Deviations: based on a Warning Letter received by the manufacturer of the recalled product for inadequate out-of specification investigations, complaint and the investigation conclusions. | Areva Pharmaceuticals Inc / 3287 vials | Class II | Terminated |
| D-0114-2021 | 11-18-2020 | Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto, Ontario Canada M9L 1T9, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6512-04 | Failed Dissolution Specifications: Out of specification for dissolution. | The Harvard Drug Group / 841 cartons | Class II | Terminated |
| D-0107-2021 | 11-18-2020 | Immune Boost with natural strawberry flavor, 8,000 IU, Supports a Healthy and Balanced Immune System, 60 mL bottle, Manufactured by: Fusion Health and Vitality, LLC. 1360 Union Hill Road, Suite 11B Alpharetta, GA 30004. | Marketed without an Approved NDA/ANDA: Product marketed with drug claims. | Fusion Health and Vitality LLC / 5000 bottles | Class II | Terminated |
| D-0154-2021 | 11-17-2020 | Kroger Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 0.5 OZ (15g), Distributed by The Kroger Co. Cincinnati, Ohio 45202 Made in Canada. NDC 30142-305-01 Package NDCs: 30142-305-01 | Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. | Taro Pharmaceuticals U.S.A., Inc. / 133,452 0.5 oz tubes | Class II | Terminated |
| D-0158-2021 | 11-17-2020 | TopCare Health, Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT. 0.5 oz. (14.2 g). Distributed by Topco Associates LLC, Elk Grove Village, IL 60007. NDC 36800-495-69 UPC 0 36800 49569 2 Package NDCs: 36800-495-69 | Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. | Taro Pharmaceuticals U.S.A., Inc. / N/A | Class II | Terminated |
| D-0151-2021 | 11-17-2020 | Equate Athlete's Foot, Clotrimazole USP 1%, Antifungal Cream, Packaged as a) NET WT. 0.5 oz (14.2g), NDC 49035-812-01, b) NET WT 2 OZ (60g), NDC 49035-812-27. Distributed by: Walmart Inc., Bentonville, AR 72716. Package NDCs: 49035-812-01; 49035-812-27 | Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. | Taro Pharmaceuticals U.S.A., Inc. / 481,896 tubes | Class II | Terminated |
| D-0105-2021 | 11-17-2020 | DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL vial, Single Dose Vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047. NDC: 63323-883-05 Package NDCs: 63323-883-05; 63323-883-10; 63323-883-30; 63323-101-61 | Cross Contamination with Other Products: trace amounts of octreotide found during testing | Fresenius Kabi USA, LLC / 16,986 vials | Class III | Terminated |
| D-0152-2021 | 11-17-2020 | H-E-B - Athlete's Foot Cream Clotrimazole Cream USP, 1% Anitfungal NET WT. 0.5 oz. (14.2 g), Made with Pride & Care for H-E-B San Antonio, TX 78204 Made in Canada NDC 37808-305-01 Package NDCs: 37808-305-01 | Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. | Taro Pharmaceuticals U.S.A., Inc. / N/A | Class II | Terminated |
| D-0155-2021 | 11-17-2020 | Kroger Jock Itch Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT .5 OZ (15 g), Distributed by The Kroger CO, Cincinnati, Ohio 45202 Made in Canada, NDC 30142-510-01 Package NDCs: 30142-510-01 | Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. | Taro Pharmaceuticals U.S.A., Inc. / 45,396 units | Class II | Terminated |
| D-0150-2021 | 11-17-2020 | CVS Health Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 1 OZ (28.4 g) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. Made in Canada NDC 59779-305-03 Package NDCs: 59779-305-01; 59779-305-02; 59779-305-03 | Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. | Taro Pharmaceuticals U.S.A., Inc. / 64,692 1 oz tubes | Class II | Terminated |
| D-0112-2021 | 11-17-2020 | ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles, Rx Only, GSMS Incorporated, Manufactured by: Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS, Incorporated, Camarillo, CA 93012 USA, NDC #60429-449-30 | FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits for the remaining shelf life of the Aripiprazole Tablets | Golden State Medical Supply Inc. / 11,922 bottles | Class II | Terminated |
| D-0120-2021 | 11-17-2020 | Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-671-05 Package NDCs: 63323-671-02; 63323-671-20; 63323-671-05; 63323-671-50; 63323-671-01; 63323-671-00 | Cross Contamination with other products: trace amounts of lidocaine | Fresenius Kabi USA, LLC / 13,525 bottles | Class I | Terminated |
| D-0118-2021 | 11-17-2020 | REGENECARE HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel, Net Wt. 3 oz. (85 g), Manufactured For: MPM Medical Mesquite, TX 75149. NDC 66977-107-03 Package NDCs: 66977-107-03 | Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia. | MPM Medical LLC / 7,637 tubes | Class I | Terminated |
| D-0156-2021 | 11-17-2020 | RiteAid Pharmacy RIngworm Cream, Clotrimazole Cream USP, 1%, Antifungal NET W 0.5 oz. (14.2g), Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011 Made in Canada. UPC 0 11822 53812 1 | Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. | Taro Pharmaceuticals U.S.A., Inc. / 34,920 0.5 oz tubes | Class II | Terminated |
| D-0149-2021 | 11-17-2020 | Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plastic drums, Manufacturer: BASF SE, Carl-Bosch-Strabe 38, 67056 Ludwigshafen, Germany, Co-Manufactured by Siegfried PharmaChemikalien Minden GmbH, D-32423 Minden | Cross contamination: the excipient was found to be contaminated with theophylline. | BASF Corporation / 4560 kg | Class II | Completed |
| D-0159-2021 | 11-17-2020 | Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT 1 oz (30 g), Distributed by: Taro Pharmaceuticals U.S.A. Inc. Hawthorne, NY 10531. Made in Canada. UPC 3 51672 20022 0 | Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. | Taro Pharmaceuticals U.S.A., Inc. / 40,896 1 oz tube | Class II | Terminated |
| D-0153-2021 | 11-17-2020 | Kaiser Permanente Clotrimazole Cream USP, 1% Antifungal Cream, NET WT 1 oz (28.4 g), Manufactured by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T1C1 Distributed by Kaiser Foundation Hospitals Livemore, CA 94551-9756. Made in Canada. NDC 0179-8014-30 | Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. | Taro Pharmaceuticals U.S.A., Inc. / 30,816 1 oz tubes | Class II | Terminated |
| D-0157-2021 | 11-17-2020 | Best Choice, Clotrimazole Cream, USP 1%, Antifungal, NET WT 0.5 OZ (14.2g), Distributed by: Valu Merchandisers, CO . 5000 Kansas Ave. Kansas City, KS 66106 Made in Canada. UPC 0-70038-20355-1 | Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. | Taro Pharmaceuticals U.S.A., Inc. / 11,088 1 oz tubes | Class II | Terminated |
| D-0115-2021 | 11-11-2020 | Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex Pharmceuticals, Inc. New Castle, DE 19720. NDC 10135-0639-30 | Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing. | InvaTech Pharma Solutions, LLC / N/A | Class III | Terminated |
| D-0100-2021 | 11-11-2020 | Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Unit-Dose Packets per carton (NDC 0591-3216-30), Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054. Package NDCs: 0591-2921-18; 0591-2921-02; 0591-3216-17; 0591-3216-30; 0591-3217-26; 0591-3217-30 | Superpotent Drug: High out-of-specification assay results were obtained during stability testing. | Teva Pharmaceuticals USA / 12,088 cartons | Class III | Terminated |
| D-0106-2021 | 11-11-2020 | Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 30 count bottle, NDC 60505-2675-3; Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 | Failed Dissolution Specifications: Out of specification for dissolution. | Apotex Corp. / a)552 bottles; b) 3192 bottles | Class II | Terminated |
| D-0109-2021 | 11-10-2020 | Levetiracetam Tablets, USP 500 mg, packaged in 120-count bottle, Rx only, Manufactured by: VKT Pharma Private Limited Srikakulam, India - 532 409, Manufactured for: Eywa Pharma Inc. 2 Research Way, Floor 3 Princeton, NJ 08540, NDC 71930-063-52 | Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets. | EYWA PHARMA INC / 5451 bottles | Class II | Terminated |
| D-0104-2021 | 11-06-2020 | clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD NDC 59746-711-30 | Failed Tablet/Capsule Specification | Jubilant Cadista Pharmaceuticals, Inc. / 4,416 bottles | Class II | Terminated |
| D-0119-2021 | 11-05-2020 | Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent Pharma. Inc. Buena, NJ 08310 NDC 52565-039-60 | Superpotent and Subpotent; low and high assay results | Teligent Pharma, Inc. / 20160 tubes | Class III | Terminated |
| D-0110-2021 | 11-03-2020 | Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-010-59 | Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results. | Teligent Pharma, Inc. / 4008 units | Class III | Terminated |
| D-0101-2021 | 11-03-2020 | Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free, For use as a sterile diluent, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, a) Vial NDC 0641-0497-17, b) Carton of 25 vials NDC 0641-0497-25. Package NDCs: 0641-0497-17; 0641-0497-25; 0641-6144-01; 0641-6144-25 | Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial. | Hikma Pharmaceuticals USA Inc. / 2,100,646 Vials | Class II | Terminated |
| D-0077-2021 | 11-01-2020 | Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size 100, Mfg: Time-Cap Labs, Inc.; Farmingdale, NY, NDC #: 68788-6932-1, Preferred Pharmaceuticals, Inc. | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. | Preferred Pharmaceuticals, Inc. / 99 bottles (9990 Extended Release Tablets) | Class II | Terminated |
| D-0070-2021 | 10-30-2020 | Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 NDC 42291-564-12 | Failed Dissolution Specifications | AVKARE Inc. / 15,678 bottles | Class II | Terminated |
| D-0111-2021 | 10-28-2020 | Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, packaged in 15 mL unit does cups (barcode 7016602715), packaged in 50-count unit dose cups per carton, Rx only, Distributed by: Lohxa, Worcester, MA 01608, NDC 70166-027-15 | Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it was contaminated with the bacteria Burkholderia lata. | Lohxa LLC / 329 cartons | Class I | Terminated |
| D-0069-2021 | 10-28-2020 | Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories, FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054, NDC 0591-2245-22. Package NDCs: 0591-2245-22 | Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing. | Teva Pharmaceuticals USA / 133,829 bottles | Class II | Terminated |
| D-0103-2021 | 10-27-2020 | Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 52376-021-04, Sunstar Americas, Inc. | Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata. | Sunstar Americas, Inc. / a) 116,662 bottles; b) 13,296 bottles | Class I | Completed |
| D-0074-2021 | 10-27-2020 | Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-771-77 Package NDCs: 68382-771-30; 68382-771-77; 68382-772-30; 68382-772-77 | Failed Dissolution Specification | Zydus Pharmaceuticals (USA) Inc / 6,840 units | Class II | Terminated |
| D-0075-2021 | 10-27-2020 | Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-772-77 Package NDCs: 68382-771-30; 68382-771-77; 68382-772-30; 68382-772-77 | Failed Dissolution Specification | Zydus Pharmaceuticals (USA) Inc / 7,908 units | Class II | Terminated |
| D-0066-2021 | 10-26-2020 | Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) blister pack, Rx only, Manufactured by: Jubilant Generics, Ltd., Roorkee, India, Marketed by: Jubilant Cardista Pharmaceuticals, Inc., Salisbury, MD NDC 59746-0306-32 | Subpotent | Jubilant Cadista Pharmaceuticals, Inc. / 23,616 blister packs | Class III | Terminated |
| D-0097-2021 | 10-26-2020 | Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg 100-count bottles, Rx Only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc. Central Islip, NY 11722, NDC 31722-943-01 Package NDCs: 31722-940-01; 31722-941-01; 31722-941-05; 31722-942-01; 31722-942-05; 31722-943-01; 31722-943-05 | Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium Tablets, USP 100 mg. | Ascent Pharmaceuticals, Inc. / 9768 Bottles | Class II | Terminated |
| D-0068-2021 | 10-23-2020 | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01 Package NDCs: 29033-055-01; 29033-055-05; 29033-055-10; 29033-056-01; 29033-056-10 | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Nostrum Laboratories Inc / 20,872 bottles | Class II | Ongoing |
