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-1017-2017 | 07-14-2017 | Hydromorphone 0.5 mg/mL in 0.9% Sodium Chloride 1 mL Fill in 3 mL BD syringe, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0302-05 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1003-2017 | 07-14-2017 | MAGNESIUM Sulfate 4 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0737-32. | Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak. | SCA Pharmaceuticals / 40 bags | Class II | Terminated |
| D-1033-2017 | 07-14-2017 | Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0833-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1021-2017 | 07-14-2017 | NORepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0774-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1024-2017 | 07-14-2017 | PHENYLephrine HCl 25 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0810-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1071-2017 | 07-14-2017 | Norepinephrine Bitartrate 16 mg Added to 0.9% Sodium Chloride 250 mL (64 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-288-18 | Lack of Sterility Assurance. | Cantrell Drug Company / 1718 bags | Class II | Terminated |
| D-0001-2018 | 07-12-2017 | Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL vial. Intravenous, Intramuscular, Subcutaneous Use, Rx Only, Hospira, Inc., Lake Forest IL USA, NDC 0406-2336-10. | CGMP Deviations: Firm failed to control impurity for color change at the API stage. | Pfizer Inc. / 32,276 10 mL vials | Class III | Terminated |
| D-1089-2017 | 07-12-2017 | Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97012 | Crystallization with subpotent out of specification assay results for chlorhexidine. | Akorn Inc / 40,978 unit dose cups | Class III | Terminated |
| D-1088-2017 | 07-12-2017 | Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC 50383-720-15), b) 100-count tray (NDC 50383-720-19), Rx Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701. | Crystallization with subpotent out of specification assay results for chlorhexidine. | Akorn Inc / 541,900 unit dose cups (5,419 trays) | Class III | Terminated |
| D-1040-2017 | 07-12-2017 | Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass vials, Rx Only, Compounded by AXIA Pharmaceutical, Los Angeles, CA 90025 | CGMP Deviations | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / 120 vials | Class II | Terminated |
| D-1090-2017 | 07-12-2017 | Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97014 | Crystallization with subpotent out of specification assay results for chlorhexidine. | Akorn Inc / 101,952 15 mL unit dose cups | Class III | Terminated |
| D-1038-2017 | 07-11-2017 | Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (NDC 55111-229-05), Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA; Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA. Package NDCs: 55111-229-30; 55111-229-90; 55111-229-01; 55111-229-05; 55111-230-30; 55111-230-90; 55111-230-01; 55111-230-05; 55111-231-30; 55111-231-90; 55111-231-01; 55111-231-05; 55111-274-30; 55111-274-90; 55111-274-01; 55111-274-05 | Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220. | Dr. Reddy's Laboratories, Inc. / 544 bottles | Class III | Terminated |
| D-0980-2017 | 07-06-2017 | Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma Limited, Hyderabad, India, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 --- NDC 0409-1140-01 | Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point | Hospira Inc., A Pfizer Company / 701 vials | Class III | Terminated |
| D-0973-2017 | 07-06-2017 | 0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container, Rx Only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B1309, NDC: 0338-0049-38 Package NDCs: 0338-0049-01; 0338-0049-02; 0338-0049-03; 0338-0049-04; 0338-0049-10; 0338-0049-41; 0338-0049-11; 0338-0049-31; 0338-0049-48; 0338-0049-18; 0338-0049-38; 0338-0043-03; 0338-0043-04 | Lack of Assurance of Sterility: Bags have the potential to leak. | Baxter Healthcare Corporation / 295,200 bags | Class II | Terminated |
| D-0972-2017 | 07-06-2017 | 5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B0089, NDC: 0338-0017-38 Package NDCs: 0338-0017-10; 0338-0017-41; 0338-0017-11; 0338-0017-31; 0338-0017-48; 0338-0017-18; 0338-0017-38; 0338-0017-02; 0338-0017-03; 0338-0017-04; 0338-0023-02; 0338-0023-03; 0338-0023-04 | Lack of Assurance of Sterility: Bags have the potential to leak. | Baxter Healthcare Corporation / 54,528 bags | Class II | Terminated |
| D-0957-2017 | 07-06-2017 | 0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Distributed in Canada by Baxter Corporation, Toronto, Ontario, Canada, Product Code: 2B1322, NDC 0338-0049-02. Package NDCs: 0338-0049-01; 0338-0049-02; 0338-0049-03; 0338-0049-04; 0338-0049-10; 0338-0049-41; 0338-0049-11; 0338-0049-31; 0338-0049-48; 0338-0049-18; 0338-0049-38; 0338-0043-03; 0338-0043-04 | Lack of Assurance of Sterility: Customer complaints for leaking bags. | Baxter Healthcare Corporation / 131,904 bags | Class II | Terminated |
| D-1084-2017 | 07-05-2017 | ULTRA-STEN Rapid Size and Strength capsules, 10 mgs, 90 count bottle, Hardcore Formulations UPC: 7 48252 68763 0 | Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine. | HARDCORE FORMULATIONS / 1490 bottles | Class I | Terminated |
| D-1085-2017 | 07-05-2017 | D-ZINE Rapid Size and Strength capsules, 10mgs, 90 count bottle, Hardcore Formulations, UPC: 7 48252 86193 1 | Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine. | HARDCORE FORMULATIONS / 1440 bottles | Class I | Terminated |
| D-1037-2017 | 07-05-2017 | Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080, NDC 68094-301-59. | Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC. | Precision Dose Inc. / 480 (5mL) unit dose cups | Class II | Terminated |
| D-0983-2017 | 06-29-2017 | Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5720-56 | Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity. | Teva Pharmaceuticals USA / 25264 bottles | Class III | Terminated |
| D-0984-2017 | 06-29-2017 | Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5721-56 | Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity. | Teva Pharmaceuticals USA / 196275 bottles | Class III | Terminated |
| D-0998-2017 | 06-28-2017 | Obagi-C Rx System C-Therapy Night Cream, Net wt. 2 oz. (57g) bottle, Rx only, Distributed by OMP, Inc., Long Beach, CA Made in USA, NDC 62032-222-02 | Labeling: Incorrect or Missing Package Insert - Obagi-C Rx System C-Therapy Night Cream is being recalled due to incomplete packaging/labeling. The bottle is missing the product insert and outer carton which contain the complete instruction for use and safety information. | Valeant Pharmaceuticals North America LLC / 844 bottles | Class III | Terminated |
| D-0944-2017 | 06-28-2017 | parodontax WHITENING (Stannous fluoride) Daily Fluoride Anticavity and Antigingivitis Toothpaste, 0.454% (0.15% w/v fluoride ion), 3.4 OZ (96.4 g) tube, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059, NDC 0135-0601-01. Package NDCs: 0135-0598-01; 0135-0598-02; 0135-0599-01; 0135-0599-02; 0135-0601-01; 0135-0601-02 | Presence of Foreign Substance: possibility of the presence of metal in the product. | GSK Consumer Healthcare / 15,708 tubes | Class II | Terminated |
| D-1052-2017 | 06-26-2017 | Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-50 | Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification. | VistaPharm, Inc. / 6150 cases | Class II | Terminated |
| D-1053-2017 | 06-26-2017 | Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-01 | Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification. | VistaPharm, Inc. / 9945 cases | Class II | Terminated |
| D-0993-2017 | 06-26-2017 | Potassium PHOSphate in 5% Dextrose Injection, 7.5 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5299 NDC# 61553-299-48 | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc / N/A | Class II | Terminated |
| D-0991-2017 | 06-26-2017 | Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5284 NDC# 61553-284-48 | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc / N/A | Class II | Terminated |
| D-0990-2017 | 06-26-2017 | Potassium PHOSphate in 0.9% Sodium Chloride Injection, 40 mMol in 250 mL in 250 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5301 NDC# 61553-301-11 | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc / N/A | Class II | Terminated |
| D-0989-2017 | 06-26-2017 | Potassium PHOSphate in 5% Dextrose Injection, 30 mMol 500 mL in 500 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5283 NDC# 61553-283-03 | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc / N/A | Class II | Terminated |
| D-0987-2017 | 06-26-2017 | Potassium PHOSphate in 0.9% Sodium Chloride Injection 15 mMol in a) 100 mL in 150 mL Intravia Bag Service Code 2K5295 NDC# 61553-295-48; b) 150 mL in 150 mL Intravia Bag Service Code 2K5292 NDC# 61553-292-01; c) 250 mL in 250 mL Intravia Bag Service Code 2K5282 NDC# 61553-282-11; d) 250 mL in 250 mL Intravia Bag with Additive Cap Service Code 2K5291 NDC# 61553-291-11, Rx Only PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc / N/A | Class II | Terminated |
| D-0992-2017 | 06-26-2017 | Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7.5 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5298 NDC# 61553-298-48NDC# 61553-298-48 | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc / N/A | Class II | Terminated |
| D-0988-2017 | 06-26-2017 | Potassium PHOSphate in 0.9% Sodium Chloride Injection 20 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5287 NDC# 61553-287-48 | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc / N/A | Class II | Terminated |
| D-0985-2017 | 06-26-2017 | Succinylcholine Chloride Injection (Preserved) 20 mg per mL, 200 mg per 10 mL, 10 mL Total Volume in BD Syringe, For IV Use, PharMedium Services, LLC, Cleveland, MS --- NDC 61553-364-65 | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc / N/A | Class II | Terminated |
| D-0997-2017 | 06-26-2017 | Potassium PHOSphate in 5% Dextrose Injection, 15 mMol in 250 mL in 250 mL Intravia Bag Service, Rx Only. PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5300 NDC# 61553-300-11 | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc / N/A | Class II | Terminated |
| D-0996-2017 | 06-26-2017 | Potassium PHOSphate in 0.9% Sodium Chloride Injection, 30 mMol in a) 250 mL in 250 mL Intravia Bag Service Code 2K5290 NDC# 61553-290-11, b) 500 mL in 500 mL Intravia Bag Service Code 2K5285 NDC# 61553-285-03, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc / N/A | Class II | Terminated |
| D-0994-2017 | 06-26-2017 | Potassium PHOSphate in 0.9% Sodium Chloride Injection, 9 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5286 NDC# 61553-286-48 | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc / N/A | Class II | Terminated |
| D-0986-2017 | 06-26-2017 | Potassium PHOSphate in 0.9% Sodium Chloride Injection, 10 mMol in a) 100 mL in 150 mL Intravia Bag (NDC 61553-288-48) Service Code: 2K5288, and b) 250 mL in 250 mL Intravia Bag (NDC 61553-281-11) Service Code: 2K5281, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc / N/A | Class II | Terminated |
| D-0995-2017 | 06-26-2017 | Potassium PHOSphate in 5% Dextrose Injection, 9 mMol in 50 mL in 50 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5310 NDC# 61553-310-41 | Lack of Assurance of Sterility; media fill failure at manufacturer | PharMedium Services, Llc / N/A | Class II | Terminated |
| D-1132-2017 | 06-23-2017 | Timolol-Latanoprost PF Solution (0.5-0.005)%, Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA | Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier | ImprimisRx CA, Inc., dba ImprimisRx / 16 bottles | Class II | Terminated |
| D-1130-2017 | 06-23-2017 | Curcumin Emulsion 10mg/ml Injection, Sterile 10 mL Multiple Dose Vial, For Slow IV Administration, Compounded for a licensed professional or patient use by ImprimisRx, Irvine, CA | Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier | ImprimisRx CA, Inc., dba ImprimisRx / 2608 vials | Class II | Terminated |
| D-1131-2017 | 06-23-2017 | Latanoprost PF Solution, 0.005%, Ophthalmic Drops in Sterile 5ml Bottles, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA | Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier | ImprimisRx CA, Inc., dba ImprimisRx / 19 bottles | Class II | Terminated |
| D-1133-2017 | 06-23-2017 | Timolol-Brimonidine-Dorzolamide-Latanoprost (0.5/0.15/2/0.005)% Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA | Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier | ImprimisRx CA, Inc., dba ImprimisRx / 2 bottles | Class II | Terminated |
| D-0974-2017 | 06-22-2017 | Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC: 68180-647-06 Package NDCs: 68180-647-06; 68180-647-01; 68180-647-02; 68180-647-03; 68180-646-06; 68180-646-01; 68180-646-02; 68180-646-03; 68180-645-06; 68180-645-01; 68180-645-02 | Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study. | Lupin Pharmaceuticals Inc. / 12480 bottles | Class III | Terminated |
| D-0954-2017 | 06-22-2017 | Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 20 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-926-25 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 72 units | Class II | Terminated |
| D-0953-2017 | 06-22-2017 | QUELICIN (Succinylcholine Chloride) Injection, USP 20 mg/mL in a) 5 mL vial (NDC 15082-814-67), b) 7mL vial (NDC 15082-814-79), c) 10mL vial (NDC 15082-814-61), Repackaged by Advanced Pharm, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. | Lack of Assurance of Sterility | Advanced Pharma Inc. / 2350 units | Class II | Terminated |
| D-0956-2017 | 06-22-2017 | Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 15 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-922-25 | Lack of Assurance of Sterility | Advanced Pharma Inc. / | Class II | Terminated |
| D-0955-2017 | 06-22-2017 | Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 30 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-924-25 | Lack of Assurance of Sterility | Advanced Pharma Inc. / | Class II | Terminated |
| D-0032-2018 | 06-22-2017 | MAN OF STEEL capsules, 3000mgs/grain, 1-count packets, Packaged for: One Drop Solutions, LLC, POB 231693, Sacramento, California 95823; [email protected]; www.manofsteelpills.com; UPC 1 0001001378 7. | Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall. | Vitility / 75 packets | Class I | Terminated |
| D-0978-2017 | 06-21-2017 | Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0841-32 | Lack of sterility assurance | SCA Pharmaceuticals / 20 bags | Class II | Terminated |
| D-0979-2017 | 06-21-2017 | Potassium PHOSphate added to 0.9% Sodium Chloride 250 mL Bag 30 mMol (44 mEq K+) Total Approximate Volume 260 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0843-40 | Lack of sterility assurance | SCA Pharmaceuticals / 20 bags | Class II | Terminated |
| D-0977-2017 | 06-21-2017 | Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0841-40 | Lack of sterility assurance | SCA Pharmaceuticals / 660 bags | Class II | Terminated |
| D-0976-2017 | 06-21-2017 | Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol (14.67 mEq K+) Total Approximate Volume 254 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0840-40 | Lack of sterility assurance | SCA Pharmaceuticals / 221 bags | Class II | Terminated |
| D-1035-2017 | 06-19-2017 | Amantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5x10) Unit Dose Cartons, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0069-15 | Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg | Apace KY LLC / 1,483 cartons | Class II | Terminated |
| D-1036-2017 | 06-19-2017 | Cyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tablets (5x10) Unit Dose Cartons, Rx Only, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0190-15 | Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg | Apace KY LLC / N/A | Class II | Terminated |
| D-0946-2017 | 06-19-2017 | Succinylcholine Chloride, 100 mg per 5mL, 20 mg per mL syringe. IV Use Only. JCB Laboratories, 8710 E 34th St., N. Wichita, KS 67226 UPC 7335968405 | Lack Of Assurance Of Sterility: voluntary recall initiated by the commercial supplier | Fagron Compounding Services LLC dba Fagron Sterile Services / 1,056 5mL syringes | Class II | Terminated |
| D-0939-2017 | 06-16-2017 | Clindamycin Injection USP; 300 mg/2 mL (150 mg/mL). 2 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-462-69 | Lack of Assurance of Sterility | Alvogen, Inc / 5,100 2 mL vials | Class II | Terminated |
| D-0940-2017 | 06-16-2017 | Clindamycin Injection USP; 600 mg/4 mL (150 mg/mL). 4 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-463-69 | Lack of Assurance of Sterility | Alvogen, Inc / 72,575 4 mL vials | Class II | Terminated |
| D-0943-2017 | 06-16-2017 | Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-1487-01) and b) 1000-count bottles ( NDC 0781-1487-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540 Package NDCs: 0781-1486-10; 0781-1486-01; 0781-1486-31; 0781-1487-10; 0781-1487-01; 0781-1487-31; 0781-1488-10; 0781-1488-01; 0781-1488-31; 0781-1489-31; 0781-1489-01; 0781-1489-10; 0781-1490-10; 0781-1490-01; 0781-1490-31; 0781-1491-10; 0781-1491-01; 0781-1491-31 | Cross Contamination With Other Product: Imipramine | Sandoz Incorporated / 38,234 bottles | Class III | Terminated |
| D-1055-2017 | 06-16-2017 | Ibuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Manufactured for: Time Cap Labs, Inc., 7 Michael Avenue Farmingdale, NJ 11735, USA, Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83 Verna Indl. Estate, Verna, Goa-403 722, India, NDC 49483-603-50 Package NDCs: 49483-602-01; 49483-602-50; 49483-603-03; 49483-603-50; 49483-603-05; 49483-603-01; 49483-604-01; 49483-604-50; 49483-604-05; 49483-604-03 | Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg. | Time-Cap Laboratories, Inc. / 1,980 bottles | Class II | Terminated |
| D-0941-2017 | 06-16-2017 | Clindamycin Injection USP; 900 mg/6 mL (150 mg/mL). 6 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-464-69 | Lack of Assurance of Sterility | Alvogen, Inc / 71,825 6 mL vials | Class II | Terminated |
| D-1126-2017 | 06-15-2017 | Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bottle containing 30 mL with an oral syringe, Rx Only, Manufactured by: Tris Pharma, Inc. Monmouth Junction, NJ 08852, NDC 27808-082-01 Package NDCs: 27808-084-01; 27808-084-02; 27808-082-01; 27808-082-02 | Defective container: Oral solution leaking from container. | Tris Pharma Inc. / 34,824 bottles | Class II | Terminated |
| D-1048-2017 | 06-15-2017 | Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-dose vial, 10 mL, For I.V. or I.M. use. a.) one vial (NDC: 0409-6629-02), b.) 25 vial carton (NDC: 0409-6629-25). Package NDCs: 0409-6629-12; 0409-6629-02; 0409-6629-25 | Lack of Sterility Assurance | Hospira a Pfizer Company / 15,034,600 10 mL multiple dose use vials | Class II | Terminated |
| D-1046-2017 | 06-15-2017 | Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4.4 mEq/mL) 15 mL, Single-dose, Caution: Must Be Diluted, Rx Only, Mfd by Hospira, Inc. Lake Forest, IL 60045 USA, NDC: 0409-7295-01 | Lack of Sterility Assurance | Hospira a Pfizer Company / 20,337,650 15 mL single dose vials | Class II | Terminated |
| D-1047-2017 | 06-15-2017 | 8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA, NDC: 0409-6625-02 | Lack of Sterility Assurance | Hospira a Pfizer Company / 91,483,150 50 mL single dose vials | Class II | Terminated |
| D-1049-2017 | 06-15-2017 | Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose vial (NDC 0409-6609-02), b.) 25 vial carton (NDC 0409-6609-25), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA | Lack of Sterility Assurance | Hospira a Pfizer Company / 21,436,700 5mL single dose vials | Class II | Terminated |
| D-0975-2017 | 06-13-2017 | CVS Health Baby Eczema Moisturizing Cream(colloidal oatmeal 1.0%), Net Wt. 7.3 oz (207g) tubes, OTC, Distributed by CVS Pharmacy Inc., Woonsocket, RI --- UPC 050428568033 | Microbial Contamination of Non Sterile Products; out of specification Total Plate Count | Sigan Industries Inc. / 19,608 tubes | Class II | Terminated |
| D-0926-2017 | 06-12-2017 | Gaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor Chewable Tablets, 80 mg & 14.2 mg, 100-count bottles, Distributed by: GlaxoSmithKline Consumer Healthcare, L.P., Moon Twp, PA 15108, UPC 3 0088-1175-47 8. | Superpotent Drug: high out-of-specification result for magnesium. | Sanofi-Aventis U.S. LLC / 2980 bottles | Class III | Terminated |
| D-0922-2017 | 06-12-2017 | Magnesium Citrate Saline Laxative Cherry Flavored, packaged in a) 10 fl. oz. (296 mL) bottle UPC: 072785104556 (Rexall's label), b) 10 fl. oz. (296 mL) bottle UPC: 041163254138 (Equaline's label), OTC, Distributed by a) Dolgencorp, LL, Goodlettsville, TN 37072 b)Supervalu, Inc. Eden Prairie, MN 55344 | Presence of foreign substance: glass particle | Vi-Jon, Inc. / 52,212 bottles | Class II | Terminated |
| D-0113-2018 | 06-09-2017 | NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-61. | Subpotent Drug: found to be below the specification for labeled assay. | Advanced Pharma Inc. / 550 syringes | Class I | Terminated |
| D-0114-2018 | 06-09-2017 | NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packaged in 8 x 5 (FORTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-67. | Subpotent Drug: found to be below the specification for labeled assay. | Advanced Pharma Inc. / 320 syringes | Class I | Terminated |
| D-0119-2018 | 06-09-2017 | NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-61. | Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system. | Advanced Pharma Inc. / 550 syringes | Class II | Terminated |
| D-0117-2018 | 06-09-2017 | NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 mL Sterile single dose syringe, packaged in 10 x 5 (FIFTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-62. | Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system. | Advanced Pharma Inc. / 50 syringes | Class II | Terminated |
| D-0116-2018 | 06-09-2017 | NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-61. | Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system. | Advanced Pharma Inc. / 4800 syringes | Class II | Terminated |
| D-0118-2018 | 06-09-2017 | NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packaged in 8 x 5 (FORTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-67. | Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system. | Advanced Pharma Inc. / 680 syringes | Class II | Terminated |
| D-0115-2018 | 06-09-2017 | NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-61. | Subpotent Drug: found to be below the specification for labeled assay. | Advanced Pharma Inc. / 50 syringes | Class I | Terminated |
| D-0948-2017 | 06-08-2017 | TetraStem brand Topical Ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company, Millerton, OK -- NDC 04307-301-11 | GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm. | Phillips Co. / 200-300 bottles | Class II | Terminated |
| D-0951-2017 | 06-08-2017 | StaphWash+Plus+ Skin Protectant, Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottle, Phillips Company, Millerton, OK -- NDC 43074-101-01 | GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm. | Phillips Co. / 10-30 bottles/units | Class II | Terminated |
| D-0949-2017 | 06-08-2017 | Diabecline brand Topical Ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company, Millerton, OK -- NDC 04307-100-11 | GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm. | Phillips Co. / 100-200 bottles | Class II | Terminated |
| D-0947-2017 | 06-08-2017 | Tetracycline-ABC Brand Topical ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company, Millerton, OK -- NDC 4307410201 | GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm. | Phillips Co. / 100-200 bottles | Class II | Terminated |
| D-0952-2017 | 06-08-2017 | VenomX, Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottles, Skin Protectant Phillips Company, Millerton, OK -- NDC 43074-207-01 | GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm. | Phillips Co. / 20-50 bottles/units | Class II | Terminated |
| D-0950-2017 | 06-08-2017 | StingMed Insect bites Skin Protectant. Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottle, Phillips Company, Millerton, OK -- NDC 04307-100-11 | GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm. | Phillips Co. / 20-50 bottles/units | Class II | Terminated |
| D-0899-2017 | 06-06-2017 | NasalCrom (cromolyn sodium) Nasal Spray, USP, 5.2 mg per spray, 200 metered sprays, 0.88 FL OZ (26 mL) metered spray pump bottle, Distributed by: Medtech Products, Inc., Tarrytown, NY 10591, UPC 8 148332 01101 7. | CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot. | Bausch & Lomb, Inc. / 44,520 bottles | Class II | Terminated |
| D-1142-2017 | 06-06-2017 | ANDROPHARM STEN Z (2, 17a-Dimethyl-17b-hydroxy-5a-androst-1-en-3-one 10mg and 17b-hydroxy-2a, 17b-dimethyl-5a-androstan-3-one azine 10 mg) capsule, packaged in 60-count bottle, Andropharm.com, UPC: 6 42125 50294 8 | Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids. | Andropharm, LLC / 150 bottles | Class I | Terminated |
| D-1143-2017 | 06-06-2017 | ANDROPHARM M1 ALPHA (Methyl-1-Etiocholenolol-Epietiocholanollone 20 mg) capsule, packaged in 60-count bottle, Amazon.com, UPC 6 42125 50292 4 | Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids. | Andropharm, LLC / 1250 bottles | Class I | Terminated |
| D-0925-2017 | 06-05-2017 | Walgreens Daytime and Nighttime Cold & Flu, packaged in combo pack of two plastic 12FL OZ (355 mL) bottles connected by one paper sleeve, TOTAL 24 FL OZ (1.5 pt)(710 mL), OTC, Distributed by: Walgreen CO., 200 Wilmot Rd., Deerfield, IL 60015 | Labeling: Label Mix-Up - This product is being recalled due to an incorrect product sleeve on the product twin pack. The incorrect product sleeve is for Day-Night Cold and Flu whereas the batch contains Day-Night Cough Liquid. | L. Perrigo Company / 1,998 combo packs | Class III | Terminated |
| D-0924-2017 | 06-05-2017 | Progesterone Injection in Olive Oil With Benzyl Alcohol 10%, 50mg/mL, 10mL Multi-Dose Vial, Rx only, Apothecary by Design, 141 Preble Street, Portland, ME. | Lack of Processing Controls: The metal container closure adheres to the rubber stopper on some of the units of the batch which can impact the integrity of the container closure. | Apothecary By Design / 25 vials | Class II | Terminated |
| D-0959-2017 | 06-05-2017 | EliquisTablets 5mg, 60 count bottle, Rx Only, Marketed by: Bristol-Meyers Squibb Company Princeton, NJ 08543 USA and Pfizer Inc. New York, NY 10017 USA, NDC 0003-0894-21 | Labeling: Label Mix-up: One bottle of Eliquis 5 mg tablet was found to contain lower-strength Eliquis 2.5 mg tablets only instead of the labeled 5 mg tablets. | Bristol-myers Squibb Company / 48,180 bottles | Class I | Terminated |
| D-0945-2017 | 06-02-2017 | G & W Clobetasol Propionate Ointment 0.05%, packaged in a) 15 g tube (NDC 0713-0656-15), b) 30 g tube (NDC 0713-0656-31, c) 45 g tube (NDC 0713-0656-37), d) 60 g tube (NDC 0713-0656-60), Rx Only, Manufactured by G & W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080 Package NDCs: 0713-0656-15; 0713-0656-31; 0713-0656-37; 0713-0656-60 | Failed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a known impurity which is a degradation product. | G & W Laboratories, Inc. / 145284 tubes | Class III | Terminated |
| D-0927-2017 | 06-01-2017 | Doxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged in a 500 cc container (NDC: 58597-8082-4), b) 100 g packaged in 16 oz container (NDC: 58597-8082-6), c) 500 g packaged in a 2500 cc container (NDC: 58597-8082-7) and a 1,000 g packaged in 1 gallon container (NDC: 58597-8082-8). For Prescription Compounding RX Only. Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical ingredient. | American Pharmaceutical Ingredients LLC / 23.5kg | Class II | Terminated |
| D-0888-2017 | 06-01-2017 | methylcobalamin 1mg/1mL, vial for injection, Rx only, MedPark Pharmacy 2002 Medical Pkwy. # 170 Annapolis, MD 21401 | Lack of Assurance of Sterility | MedPark Pharmacy, LLC / 1 (5mL) vial | Class II | Terminated |
| D-0938-2017 | 06-01-2017 | Chlorhexidine Gluconate 0.12% Oral Rinse, USP, 1 Pint (473 ml), Rx Only, Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056, NDC 0116-2001-16 Package NDCs: 0116-2001-16; 0116-2001-04; 0116-2001-15; 0116-2001-05; 0116-2001-06; 0116-2001-07 | CGMP Deviations | Xttrium Laboratories Inc / 36,720 16 oz. glass bottles | Class II | Terminated |
| D-0887-2017 | 06-01-2017 | Option 2, Levonorgestrel Tablet, 1.5 mg, Emergency Contraceptive, 1 Tablet per box, Distributed By Perrigo, Allegan, MI 49010. NDC 0113-2003-12 Package NDCs: 0113-2003-12 | Defective Container: Carton is missing the tablet blister strip and tablet. | L. Perrigo Company / 181,776 (units/eaches) | Class II | Terminated |
| D-0921-2017 | 06-01-2017 | Venlafaxine Hydrochloride Extended-Release Capsules USP, 75 mg, packaged in a) 30-count bottles (NDC 52343-132-30) and b) 90-count bottles (NDC 52343-132-90), Rx only, Distributed by: Lucid Pharma LLC, 2 Tower Center Blvd, Suite-1101-B, East Brunswick, NJ 08816 USA. | Failed Tablet/Capsules Specifications: pharmacists complaints for bottles containing melted capsules. | Lucid Pharma LLC / a) 44168 bottles; b) 24960 bottles | Class II | Terminated |
| D-0960-2017 | 05-31-2017 | Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, NDC: 0591-3693-19 | Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which was below specification for one tablet. Teva cannot at this time exclude the potential for additional tablets to be below specification. | Teva Pharmaceuticals / 360 bottles | Class I | Terminated |
| D-0928-2017 | 05-30-2017 | BuPROPion HCL Tablets, USP, 75 mg, packaged as UD 100 tablets (10x10), Rx Only, Mfg by: Sandoz Inc., 508 Carnegie Center, Suite 400, Princeton, NJ 08805, NDC: 63739-706-10 | Failed Moisture Limits: Product tested out-of-specification for moisture content. | Mckesson Packaging Services / 942 cartons | Class III | Terminated |
| D-0937-2017 | 05-26-2017 | Methocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500 g container (NDC: 58597-8023-7), c) 1,000 g container (NDC: 58597-8023-8). For Prescription Compounding RX Only. Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of quality assurance at the API manufacturer. | American Pharmaceutical Ingredients LLC / 5,000g (5 kg) | Class II | Terminated |
| D-1117-2017 | 05-25-2017 | CaverFlo Natural Herbal Coffee, 25 g, supplied in boxes of 10 packets, manufacture for Caverflo Texas Trading -- UPC: 9555671709987 | Marketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, tadalafil and undeclared milk | Brian P. Richardson / Unknown | Class I | Terminated |
| D-0958-2017 | 05-25-2017 | BRILINTA (ticagrelor) tablets, 90 mg, 8-count Professional Sample bottles, Rx only, Mfd. for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850; By: AstraZeneca AB, SE-151 85 Sodertalje, Sweden, NDC 0186-0777-08. Package NDCs: 0186-0777-08; 0186-0777-60; 0186-0777-18; 0186-0777-39; 0186-0777-28; 0186-0776-60; 0186-0776-94 | Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled as BRILINTA 90 mg tablets contained 5 ZURAMPIC 200 mg tablets, in addition to the expected 8 BRILINTA tablets. | AstraZeneca Pharmaceuticals, LP / 40,368 bottles | Class I | Terminated |
| D-0981-2017 | 05-24-2017 | Mefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distributed by: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981, NDC 66993-070-30 | Failed Dissolution Specifications: Low dissolution results were obtained during stability testing | Shionogi Inc. / 6304 bottles | Class III | Terminated |
| D-0219-2018 | 05-24-2017 | Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed by Prasco Laboratories, Mason, OH 45040, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ 07981, NDC 66993-070-30 | Presence of foreign substance: The recall was initiated due to black particles being observed while performing routine post-release stability testing on Mefenamic acid capsules | Shionogi Inc. / 968 bottles | Class III | Terminated |
