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 10, 2025 and include a total of 17129 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0929-2018 | 06-12-2018 | ceFAZolin 2 gm in NS 100mL. ceFAZolin Sodium (USP) 2gm, 0.9% Sodium Chloride (USP) 100mL. Volume 110 mL. Single dose bag. Avella of Houston 9265 Kirby Dr., Houston, TX 77054 NDC: 42852-604-10 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 2,500 bags | Class II | Terminated |
| D-0939-2018 | 06-12-2018 | NORepiNEPHrine 8 mg (norepinephrine Bitartrate (USP) 8 mg added to 5% Dextrose Inj. (USP) 250 mL. (Concentration 32 mcg/mL) Volume: 258 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-815-25 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 4,280 bags | Class II | Terminated |
| D-0951-2018 | 06-12-2018 | MAGnesium 1gm in NS 100 mL (MAGnesium SULfate (USP) 1 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 102 mL. Single dose bag. For: Salt Lake Regional Med Ctr By: Avella of Houston, 9256 Kirby Dr., Houston, TX 77054. NDC: 42852-906-10 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 25 bags | Class II | Terminated |
| D-0930-2018 | 06-12-2018 | ePHEDrine 50mg, 50 mg/10 mL (5 mg per mL) (Ephedrine Sulfate, USP 50mg in 0.9% Sodium Chloride, USPQS 10mL. 10 mL-Sterile use dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-61 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 5400 syringes | Class II | Terminated |
| D-0956-2018 | 06-12-2018 | Midazolam 0.5mg/mL (Midazolam HCL (USP) 50 mg, 0.9% Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. For: Coral Gables Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-408-10 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 220 bags | Class II | Terminated |
| D-0943-2018 | 06-12-2018 | ePHEDrine Sulfate, USP 50mg in 0.9% Sodium Chloride USP QS 10mL. 50 mg/10 mL (5 mg/mL). Volume: 10 mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-891-61 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 500 syringes | Class II | Terminated |
| D-0941-2018 | 06-12-2018 | Vancomycin 1.25gm in D5W 250 mL. ( Vancomycin HCL (USP) 1.25 gm, 5% Dextrose Inj. (USP) 250 mL) Volume: 262 mL. Single dose bag. Avella Specialty Pharmacy, 24416N 19th Avenue, Phoenix, AZ 85085. NDC 42852-617-25 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 1,352 bags | Class II | Terminated |
| D-0960-2018 | 06-12-2018 | NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 5% Dextrose Inj. (USP) 250 mL (Concentration 16 mcg/mL) Volume: 254 mL Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-807-25 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 2280 bags | Class II | Terminated |
| D-0958-2018 | 06-12-2018 | NORepiNEPHrine 16 (NORepiNEPHrine Bitartrate (USP) 16 mg, 5% Dextrose Inj. (USP) 250 mL. Volume: 266 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-834-25 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 520 bags | Class II | Terminated |
| D-0933-2018 | 06-12-2018 | fentaNYL (10 mcg per mL) in 0.95 Sodium Chloride, USP QS 1mL. Volume 1mL. Single dose Syringe. For: Hunt Regional Medical Center, By: Advanced Pharma, 9265 Kirby Dr,., Houston, TX 77054. NDC 15082-210-70 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 120 syringes | Class II | Terminated |
| D-0942-2018 | 06-12-2018 | 0.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg, 0.9% Sodium Chloride, USP QS 250 mL). Volume 250 mL. Single dose Cassette. For: Parkland Memorial Hospital. By: Advanced Pharma, 9225 Kirby Dr. Houston, TX 77054. Parkland Memorial Hospital NDC 15082-002-87 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 20 bags | Class II | Terminated |
| D-0948-2018 | 06-12-2018 | HEPARIN 1,000 Units in NS 250mL. (Heparin Sodium, USP 1,000 Units, 0.9% Sodium Chloride, USP 250 mL) Volume: 251 mL. Single dose bag. For: Adventist Medical Center Hanford. By: Avella of Huston, 9265 Kirby Dr., Houston TX, 77054. NDC 42852-747-25 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 40 bags | Class II | Terminated |
| D-0963-2018 | 06-12-2018 | ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP QS 5mL. Volume 5 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-67 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 10500 syringes | Class II | Terminated |
| D-0950-2018 | 06-12-2018 | HYDROmorphone 0.2mg/mL. (Hydromorphone HCL (USP) 20 mg, 0.9% Sodium Chloride (USP) QS 100 mL) Volume: 100mL. Single dose bag. Advanced Pharma, 9265 Kirby Dr., Houston,077054 TX. NDC 15082-221-10 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 660 bags | Class II | Terminated |
| D-0938-2018 | 06-12-2018 | MORphine 1 mg/mL (Morphine Sulfate, USP 100mg, 0.9% Sodium Chloride, USP QS 100 mL). Volume 100 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-241-10 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 1500 bags | Class II | Terminated |
| D-0934-2018 | 06-12-2018 | HEPARIN 25,000 Units in 5% Dextrose (Heparin Sodium, USP 25,000 Units, 5% Dextrose Inj., USP 250 mL) Volume: 255 mL. Single dose bag. Avella Specialty Pharmacy, 24416 N 19th Avenue, Pheonix AZ 85085. NDC 42852-729-25 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 240 bags | Class II | Terminated |
| D-0949-2018 | 06-12-2018 | HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 30 mg, 0.9% Sodium Chloride (USP) QS 30 mL) Volume: 30mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX. NDC 42852-222-63 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 480 syringes | Class II | Terminated |
| D-0886-2018 | 06-12-2018 | Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-121-90 Package NDCs: 55111-121-30; 55111-121-60; 55111-121-90; 55111-121-05; 55111-121-10; 55111-122-30; 55111-122-60; 55111-122-90; 55111-122-05; 55111-122-10; 55111-123-30; 55111-123-60; 55111-123-90; 55111-123-05; 55111-123-10 | Failed Impurities/Degradation Specifications | Dr. Reddy's Laboratories, Inc. / 55,126 bottles | Class III | Terminated |
| D-0888-2018 | 06-12-2018 | Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90 and b) 500-count bottle (NDC 55111-123-05), Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA Package NDCs: 55111-121-30; 55111-121-60; 55111-121-90; 55111-121-05; 55111-121-10; 55111-122-30; 55111-122-60; 55111-122-90; 55111-122-05; 55111-122-10; 55111-123-30; 55111-123-60; 55111-123-90; 55111-123-05; 55111-123-10 | Failed Impurities/Degradation Specifications | Dr. Reddy's Laboratories, Inc. / 130,081 bottles | Class III | Terminated |
| D-0887-2018 | 06-12-2018 | Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-122-90 Package NDCs: 55111-121-30; 55111-121-60; 55111-121-90; 55111-121-05; 55111-121-10; 55111-122-30; 55111-122-60; 55111-122-90; 55111-122-05; 55111-122-10; 55111-123-30; 55111-123-60; 55111-123-90; 55111-123-05; 55111-123-10 | Failed Impurities/Degradation Specifications | Dr. Reddy's Laboratories, Inc. / 44,894 bottles | Class III | Terminated |
| D-0874-2018 | 06-11-2018 | Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box, Manufactured For: MedGyn Products, Inc., 100 W. Industrial Rd., Addison, IL 60101 USA; Manufactured By: BioDiagnostics Intl, 555 West Lambert Road Unit-C, Brea, CA 92821, NDC 42721-112-08. | CGMP Deviations: Products not manufactured under current good manufacturing practices. | BioDiagnostic International / 1000 boxes | Class II | Terminated |
| D-0891-2018 | 06-08-2018 | Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-401-02. Package NDCs: 50742-401-02; 50742-402-05 | Superpotent Drug: High out of specification assay value results for potency. | Ingenus Pharmaceuticals Llc / 14089 vials | Class II | Terminated |
| D-0890-2018 | 06-08-2018 | Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-402-05. Package NDCs: 50742-401-02; 50742-402-05 | Superpotent Drug: High out of specification assay value results for potency. | Ingenus Pharmaceuticals Llc / 34964 vials | Class II | Terminated |
| D-0893-2018 | 06-08-2018 | TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-120-01 | Labeling: Incorrect or Missing Lot and/or Exp Date. | Qualgen, LLC / | Class III | Terminated |
| D-0892-2018 | 06-08-2018 | ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-020-01 | Labeling: Incorrect or Missing Lot and/or Exp Date. | Qualgen, LLC / 2,940 pellets | Class III | Terminated |
| D-0877-2018 | 06-07-2018 | Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-0464-01 | Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification. | Mylan Pharmaceuticals Inc. / 1,620 bottles | Class III | Terminated |
| D-1040-2018 | 06-06-2018 | Kit for the Preparation of Technetium Tc99m Medronate, 20mg in 10 mL vial, packaged in a) 5-count box (NDC 45567-0040-1), b) 30-count box, NDC 45567-0040-2 , Rx only, Manufactured by: Pharmalucence, Inc., Billerica, MA 01821. Package NDCs: 45567-0040-1; 45567-0040-2 | Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility. | Pharmalucence, Inc. / 95 kits | Class II | Terminated |
| D-0854-2018 | 06-05-2018 | HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in 3 mL syringe, Rx, PharMEDium Services, LLC, Dayton, NJ | Superpotent and Subpotent | PharMEDium Services, LLC / 2,800 syringes | Class II | Terminated |
| D-0906-2018 | 06-04-2018 | Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use cartridge syringe, Single unit (NDC 0409-1782-03) and 10 count box (NDC 0409-1782-69), Rx Only, Hospira Inc., Lake Forest, IL Package NDCs: 0409-1782-03; 0409-1782-69 | Presence of Particulate Matter; Potential for particulate matter on the syringe plunger. | HOSPIRA INC, LAKE FOREST / 164,860 syringes | Class I | Terminated |
| D-0883-2018 | 05-31-2018 | 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-23 | Lack of assurance of sterility: Bags have potential to leak. | ICU Medical Inc / 525984 bags | Class II | Terminated |
| D-0884-2018 | 05-31-2018 | 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-37 | Lack of assurance of sterility: Bags have potential to leak. | ICU Medical Inc / 1247200 bags | Class II | Terminated |
| D-0881-2018 | 05-31-2018 | 0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7730-37 | Lack of assurance of sterility: Bags have potential to leak. | ICU Medical Inc / 88960 bags | Class II | Terminated |
| D-0885-2018 | 05-31-2018 | 5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7922-02 | Lack of assurance of sterility: Bags have potential to leak. | ICU Medical Inc / 267288 bags | Class II | Terminated |
| D-0882-2018 | 05-31-2018 | 0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7983-02 | Lack of assurance of sterility: Bags have potential to leak. | ICU Medical Inc / 941496 bags | Class II | Terminated |
| D-0841-2018 | 05-31-2018 | Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered Sprays bottles, 16 g net fill weight, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326, NDC 60505-0829-1 Package NDCs: 60505-0829-1 | Presence of foreign substance: glass particles | Apotex Inc. / Unknown | Class II | Terminated |
| D-0878-2018 | 05-30-2018 | Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-124-90 UPC 355111124900 Package NDCs: 55111-124-30; 55111-124-60; 55111-124-90; 55111-124-05; 3551111249 | Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle. | Dr. Reddy's Laboratories, Inc. / 6,397 bottles | Class II | Terminated |
| D-0865-2018 | 05-29-2018 | Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-4810-05 Package NDCs: 0121-0810-02; 0121-0810-16; 0121-4810-05; 0121-4810-40; 0121-4810-00; 0121-4810-50 | Resuspension problems: Out of specification for appearance and resuspendability. | Pharmaceutical Associates Inc / 275400 cups | Class III | Terminated |
| D-0860-2018 | 05-25-2018 | Acne Shave (salicylic acid) Shave Cream Acne Shield, 0.5%, 5.1 FL OZ (150 mL) tube, Distributed by: United Exchange Corp., 17311 Valley View Blvd, Cerritos, CA 90703 USA, UPC 7 80707 73111 6. | CGMP Deviations: products may be contaminated with bacteria. | Shadow Holdings DBA Bocchi Labs / 8,208 tubes | Class II | Terminated |
| D-0861-2018 | 05-25-2018 | Acne Shave 3 Step Shaving System, contains one tube Acne Shave (salicylic acid) Shave Cream Acne Shield, one tube Acne Shave Post-Shave Moisturizer (salicylic acid), 0.5% tube, and one Power Shaver per box, Distributed by: United Exchange Corp., 17311 Valley View Blvd, Cerritos CA 90703 USA, UPC 7 80707 73114 7. | CGMP Deviations: products may be contaminated with bacteria. | Shadow Holdings DBA Bocchi Labs / 4,932 boxes | Class II | Terminated |
| D-0859-2018 | 05-25-2018 | Acne Shave Post-Shave Moisturizer (salicylic acid), 0.5%, 3.3 FL OZ (98 mL) tube, Distributed by: United Exchange Corp., 17211 Valley View Blvd., Cerritos, CA 90703 USA, UPC 7 80707 73112 3. | CGMP Deviations: products may be contaminated with bacteria. | Shadow Holdings DBA Bocchi Labs / 15,216 tubes | Class II | Terminated |
| D-0858-2018 | 05-25-2018 | X-Jow (menthol USP) Pain Gel, 1.25%, packaged in a) 4 oz. (113g) bottles (UPC 850547 00502 6) and b) 8 oz. (226g) bottles (UPC 8 50547 00503 3, Distributed by Herb-X Solutions, Inc., 3838 West Burbank Blvd., Burbank CA 91505. | CGMP Deviations: products may be contaminated with bacteria. | Shadow Holdings DBA Bocchi Labs / 12,252 bottles | Class II | Terminated |
| D-0876-2018 | 05-25-2018 | Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-363-90 Package NDCs: 59746-360-30; 59746-360-90; 59746-360-05; 59746-360-03; 59746-361-30; 59746-361-90; 59746-361-05; 59746-361-03; 59746-362-30; 59746-362-90; 59746-362-05; 59746-362-03; 59746-363-30; 59746-363-90; 59746-363-67; 59746-363-32 | Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone). | Jubilant Cadista Pharmaceuticals, Inc. / 2,328 bottles (Lot VR417065A) and 2,352 bottles (Lot VR417066A) | Class III | Terminated |
| D-0836-2018 | 05-24-2018 | Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 212020 NDC 43386-356-10 UPC 343386356102 Package NDCs: 43386-358-05; 43386-358-01; 43386-358-10; 43386-358-03; 43386-357-01; 43386-357-05; 43386-357-10; 43386-357-03; 43386-356-01; 43386-356-05; 43386-356-10; 43386-356-03; 3433863561 | Labeling: Missing Label | LUPIN SOMERSET / 1,672 (1000-count) bottles | Class III | Terminated |
| D-0875-2018 | 05-24-2018 | Allergan Taytulla Softgel Capsules, 1 mg/20 mcg, 6x28 blister card Physicians's Sample - Not for Sale Distributed by: Allergan USA INC Irvine, CA 92612 NDC 0023-5862-28 (Blister Card) NDC 0023-5862-29 (Blister Carton) NDC 0023-5862-31 (Outer carton) UPC 300235862290 Package NDCs: 0023-5862-28; 0023-5862-30; 0023-5862-29; 0023-5862-31; 3002358622 | Contraceptive Tablets Out of Sequence. | Allergan, PLC. / 168,768 blister cards (4,725,504 softgel capsules) | Class I | Terminated |
| D-0855-2018 | 05-22-2018 | READYFLUSH PROTECT with Dimethicone (3.2%), Flushable Personal Cleaning Cloths, 24-count flexible pack. Manufactured by Medline Industries, Inc. Mundelein, IL 60060 USA. NDC 53329-066-58. | Microbial Contamination of a Non-Sterile Product. | Medline Industries Inc (Northpoint Services) / 19,0800 24-count flexible packs | Class II | Terminated |
| D-1067-2018 | 05-17-2018 | Cefazolin 2 Gm/20 mL 20 ml. Rx Only. Packaged in 20 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 60 20-ml syringes | Class II | Terminated |
| D-1051-2018 | 05-17-2018 | Morphine Sulfate 1 mg/mL CADD 25 mL . RX only. Packaged in a CADD 25 ml. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 20 25-ml CADD | Class II | Terminated |
| D-1064-2018 | 05-17-2018 | Ropivacaine HCl 2 mg/mL 400 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 20 400-ml ON-Q Pump | Class II | Terminated |
| D-1061-2018 | 05-17-2018 | Medroxyprogesterone 150 mg/mL 5ml. Rx Only. Packaged in 5 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 60 5-ml vials | Class II | Terminated |
| D-1063-2018 | 05-17-2018 | Fentanyl Citrate 50 mcg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 300 2-ml syringes | Class II | Terminated |
| D-1070-2018 | 05-17-2018 | Glutathione 200 mg/mL 50 ml MDV. Rx Only. Packaged in 50 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 100 50-ml vials | Class II | Terminated |
| D-0880-2018 | 05-17-2018 | 7K capsules packaged in single packs sold in 24-count boxes, Distributed by SX Power Co. San Diego, CA 92108, UPC 601577513148 | Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. | Shoreside Enterprises Inc. / Unknown | Class I | Terminated |
| D-0879-2018 | 05-17-2018 | POSEIDON Xtreme PLATINUM 4500,1000mg, packaged in single packs sold in 24-count boxes, Distributed by: Poseidon Distribution Atlanta, GA, UPC 638632428857 | Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. | Shoreside Enterprises Inc. / Unknown | Class I | Terminated |
| D-1071-2018 | 05-17-2018 | Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 2000 100-ml vials | Class II | Terminated |
| D-1056-2018 | 05-17-2018 | Glutathione 200 mg/mL 100ml. Rx Only. Packaged in 100 mL MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 2400 100-ml vials | Class II | Terminated |
| D-1057-2018 | 05-17-2018 | Glycopyrrolate 0.2 mg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 100 2-ml syringes | Class II | Terminated |
| D-1054-2018 | 05-17-2018 | B-Complex Rx only. packaged in a) 100 mL bag b) 100 ml MDV vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 2600 100 ml bags/vials | Class II | Terminated |
| D-1073-2018 | 05-17-2018 | Phenol 6% with Glycerin Inj 10 ml. Packaged in 10 ml vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 40 10-ml vials | Class II | Terminated |
| D-1068-2018 | 05-17-2018 | Glutathione 200 mg/mL 100 ml. Rx Only. Packaged in 50ml MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 100 50-ml vials | Class II | Terminated |
| D-1053-2018 | 05-17-2018 | Ascorbic Acid 500 mg/mL 500 mL TPN. Rx Only. Packaged in 500 ml bag. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 5000 500-ml bags | Class II | Terminated |
| D-1058-2018 | 05-17-2018 | Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 2 1-ml vials | Class II | Terminated |
| D-1055-2018 | 05-17-2018 | EDTA Disodium 30 mg/mL PF. Rx Only. Packaged in 1 mL pre filled syringe. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 1 1-ml syringe | Class II | Terminated |
| D-1072-2018 | 05-17-2018 | MIC "B" COMBO LIPOTROPIC 50 ml. Packaged in a 50ml MDV vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 250 50-ml vials | Class II | Terminated |
| D-1059-2018 | 05-17-2018 | Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL syringes. Refridgerate. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 442 1-ml syringes | Class II | Terminated |
| D-1069-2018 | 05-17-2018 | Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 250 10-ml syringes | Class II | Terminated |
| D-0838-2018 | 05-17-2018 | My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454 775, INDIA, UPC 3 68180 85212 4. | Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release. | Lupin Pharmaceuticals Inc. / 43,640 cartons | Class II | Terminated |
| D-1066-2018 | 05-17-2018 | Ropivacaine HCl 2 mg/mL 750 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 3 750-ml ON-Q Pump | Class II | Terminated |
| D-1060-2018 | 05-17-2018 | Magnesium Sulfate 200 mg/mL, 100ml. Rx. Only. Packaged in 100 mL MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 1000 100-ml vials | Class II | Terminated |
| D-1065-2018 | 05-17-2018 | Ropivacaine HCl 2 mg/mL 550 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 25 550-ml ON-Q Pump | Class II | Terminated |
| D-1052-2018 | 05-17-2018 | Ascorbic Acid 500 mg/mL 100 mL vial. Rx Only. Packaged in a 100 ml vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 4900 100-ml vials | Class II | Terminated |
| D-1062-2018 | 05-17-2018 | Methylene Blue 10 mg/mL 1ml. Packaged in 1 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 95 1-ml syringes | Class II | Terminated |
| D-0837-2018 | 05-17-2018 | My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, GAVIS Pharmaceuticals, A Lupin Group Company; Mfg. for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, UPC 3 43386-622-31 3. | Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release. | Lupin Pharmaceuticals Inc. / 43,922 cartons | Class II | Terminated |
| D-0834-2018 | 05-16-2018 | screamin' hot (capsaicin) Pain Relieving Gel, 0.03%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80072 4; b) 5 oz. (141g) tubes, UPC 7 50263 80007 6; and c) 16 oz. (454g) bottles, UPC 7 50263 80076 2; MFD FOR: Toast Products, 400 Sproul Street, Pittsburgh, PA 15136; NDC 52099-8005. | CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products. | Ideaz Llc / 820.125 pounds | Class II | Terminated |
| D-0864-2018 | 05-16-2018 | Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak, LTD, Ringwood, NJ | Microbial contamination of NonSterile Product; FDA analysis returned out of specification results for total aerobic microbial counts | Inopak Ltd / 1345 cases | Class II | Terminated |
| D-0835-2018 | 05-16-2018 | screamin' menthol (menthol) Pain Relieving Gel, 4%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80062 5; b) 5 oz. (141g) tubes, UPC 7 50263 80006 9; and c) 16 oz. (454g) bottles, UPC 7 50263 80066 3; MFD FOR: Toast Products, 400 Sproul Street, Pittsburgh, PA 15136; NDC 52099-8010. | CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products. | Ideaz Llc / 800 pounds | Class II | Terminated |
| D-0871-2018 | 05-15-2018 | Expectorant Cough Syrup, Homeopathic Syrup for Temporary Relief of Cough & Bronchitis. 8 Fl Ounces amber PET bottle with black cap. MBi Nutraceuticals 211 N 1800 W, Lindon, UT 84042. Bar Code: 3 58301 08214 1 | Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing. | MBi Distributing Inc. dba MBi Nutraceuticals / 1,971 bottles | Class II | Terminated |
| D-0870-2018 | 05-15-2018 | Stomach Calm, Calms Upset Stomach and Aids in Treatment of Simple Diarrhea, 8 fl. oz., liquid 8 ounce amber PET bottle with Black CRC Cap, MBi Nutraceuticals Lindon, UT 84042. Bar Code: 3 58301 38414 2 | Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing. | MBi Distributing Inc. dba MBi Nutraceuticals / 343 bottles | Class II | Terminated |
| D-0869-2018 | 05-15-2018 | Intestinal Colic Drops, Homeopathic Drops for Temporary Relief of Flatulent Colic, 1 ounce amber glass bottle with glass dropper, liquid, Meteorism, and Porphyrinuria. MBi Nutraceuticals Lindon, UT 84042 | Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing. | MBi Distributing Inc. dba MBi Nutraceuticals / 78 bottles | Class II | Terminated |
| D-0873-2018 | 05-15-2018 | Silver-Zinc Throat Spray, HOMEOPATHIC IMMUNE DEFENSE, 50PPM, 4oz/50 ppm/ 120ml,amber PET bottle with white sprayer. MBi Nutraceuticals Lindon, Utah 84042 USA. Bar Code: 3 58301 18118 9 | Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing. | MBi Distributing Inc. dba MBi Nutraceuticals / 134 bottles | Class II | Terminated |
| D-0868-2018 | 05-15-2018 | Nausea Drops, Homeopathic Drops for Temporary Relief of Motion Sickness, Morning Sickness, and General Nausea, 1 Fl. Ounce amber glass bottle with glass dropper. MBi Nutraceuticals Lindon, UT 84042. Bar Code: 1 58301 04711 4 | Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing. | MBi Distributing Inc. dba MBi Nutraceuticals / 48 bottles | Class II | Terminated |
| D-0867-2018 | 05-15-2018 | Teething Drops, Homeopathic Drops for Temporary Relief of Pain Caused by Teething, 1 Fl Ounce glass amber bottle with glass dropper, MBi Nutraceuticals, Lindon, UT 84042. Bar Code: 3 58301 04011 0 | Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing. | MBi Distributing Inc. dba MBi Nutraceuticals / 121 bottles | Class II | Terminated |
| D-0872-2018 | 05-15-2018 | Argentum Elixir Colloidal Silver, 50 PPM Homeopathic Infection Fighter, 8 fl oz. amber PET bottle with white sprayer. MBi nutraceuticals Lindon UT, 84042. Bar COde: 3 58301 18114 1 | Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing. | MBi Distributing Inc. dba MBi Nutraceuticals / 1,688 bottles | Class II | Terminated |
| D-0816-2018 | 05-11-2018 | Scopolamine Transdermal Therapeutic System, 1 mg/3 days, a) 4-count (NDC 45802-580-84); b) 10-count (NDC 45802-580-46); c) 24-count (NDC 45802-580-62), Rx only, Mfd. by: Aveva Drug Delivery Systems, A Nitto Denko Company, Miramar, FL 33025 Distributed by Perrigo, Allegan, MI 49010 Package NDCs: 45802-580-84; 45802-580-46; 45802-580-62; 45802-580-01 | Defective delivery system | L. Perrigo Company / 569,520 cartons | Class II | Terminated |
| D-0840-2018 | 05-08-2018 | Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0688-4 | Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency | Apotex Inc. / 13453 vials | Class I | Terminated |
| D-0839-2018 | 05-08-2018 | Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials per carton, Rx Only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0687-4 | Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency | Apotex Inc. / 121693 vials | Class I | Terminated |
| D-0850-2018 | 05-07-2018 | Geritrex Senna Syrup (sennosides 8.8mg), packaged in 8 FL OZ. (236 mL) bottle, Distributed by Geritrex, LLC 144 Kingsbridge Rd East Mt Vernon, NY 10550, 1-800-736-3437, NDC 54162-007-08, UPC 354162007088 | CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample. | RIJ Pharmaceutical LLC / 31411 bottles | Class II | Terminated |
| D-0843-2018 | 05-07-2018 | Preferred Plus Pharmacy Antacid (Aluminum Hydroxide 200mg, Magnesium Hydroxide 200mg Simethicone 20mg, packaged in 12 FL. OZ. (355 mL) bottles, Manufactured By: RIJ PHARMACEUTICAL CORPORATION 40 Commercial Avenue Middletown, NY 10941, Distributed by: Kinray Inc. Whitestone, NY 11357, NDC 53807-12612, UPC 53807126122 | CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample. | RIJ Pharmaceutical LLC / N/A | Class II | Terminated |
| D-0845-2018 | 05-07-2018 | RPC Children's Non-Aspirin (Acetaminophen 160 mg) Elixir, packaged in 4 FL. OZ. (118 mL), RIJ PHARMACETUICAL CORPORATION, 40 COMMERCIAL AVENUE, MIDDLETOWN, NY 10941, NDC 53807-129-04, UPC 353807129048 | CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample. | RIJ Pharmaceutical LLC / 1272 bottles | Class II | Terminated |
| D-0846-2018 | 05-07-2018 | Gericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg/5mL, packaged in 16 FL OZ (473 mL), Dist. By Gericare Pharmaceuticals 1650 63rd Street Brooklyn, NY 11204, NDC 5789618016, UPC 357896180164 | CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample. | RIJ Pharmaceutical LLC / 13380 bottles | Class II | Terminated |
| D-0847-2018 | 05-07-2018 | RPC APAP Elixir (Acetaminophen 160mg), Packaged in 16 FL. OZ. (473 mL) bottles, RIJ PHARMACEUTICAL CORPORATION, 40 COMMERCIAL AVENUE, MIDDLETOWN, NY, NDC 53807-129-16, UPC 353807129161 | CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample. | RIJ Pharmaceutical LLC / 228 bottles | Class II | Terminated |
| D-0842-2018 | 05-07-2018 | Preferred Plus Pharmacy Antacid Extra Strength (Aluminum Hydroxide 400mg, Magnesium Hydroxide 400mg, Simethicone 40 mg), packaged in 12 FL. OZ. (355 mL), Manufactured By: RIJ Pharmaceutical Corp.40 Commercial Avenue, Middletown, NY 10941, Distributed by: Kinray Inc. Whitestone, NY 11357 NDC 53807-158-12, UPC 353807158123 | CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample. | RIJ Pharmaceutical LLC / 5043 bottles | Class II | Terminated |
| D-0853-2018 | 05-07-2018 | Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg, packaged in 16 fl oz. (473 mL) bottles, Dist by: Gericare Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-709-16, UPC 57896709167 | CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample. | RIJ Pharmaceutical LLC / 8124 bottles | Class II | Terminated |
| D-0849-2018 | 05-07-2018 | Ritussin DM Dextromethorphan Hydrobormide (Dextromethorphan HBr, USP 10 mg, Guaifenesin, USP 100mg), packaged in 4 FL.OZ. (118 mL), RIJ PHARMACEUTICAL CORPORATION 40 COMMERCIAL AVENUE, MIDDLETOWN, NY 10941, NDC 5380740904, UPC 35380740941 | CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample. | RIJ Pharmaceutical LLC / 9240 bottles | Class II | Terminated |
| D-0852-2018 | 05-07-2018 | Gericare Diocto Liquid (Docusate Sodium 50mg), 50 mg/5 mL, packaged in 16 FL OZ (473 mL) bottles, Dist by: Gericare Pharmaceuticals Corp. 1650 63rd Street, Brooklyn, NY 11204, NDC 57896-403-16, UPC 357896-403164, | CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample. | RIJ Pharmaceutical LLC / 12756 bottles | Class II | Terminated |
| D-0844-2018 | 05-07-2018 | RPC Senna Syrup (Sennosides 8.8mg), packaged in 8 fl oz (237 mL) bottles, RIJ Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NJ 10941, NDC 5380755608, UPC 353807556080 | CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample. | RIJ Pharmaceutical LLC / 1505 bottles | Class II | Terminated |
| D-0848-2018 | 05-07-2018 | GeriCare Senna Syrup (Sennosides 8.8 mg), 8 fl oz (237 mL) bottles, Dist, by Gericare Pharmaceuticals 1650 63rd Street Brooklyn, NY 11204, NDC 57696-452-08, UPC 357896452087 | CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample. | RIJ Pharmaceutical LLC / 21213 bottles | Class II | Terminated |
| D-0817-2018 | 05-07-2018 | Hydrocortisone Ointment, USP 2.5%, Net Wt. 20g, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed by Perrigo, Allegan MI 49010, NDC 45802-014-02 Package NDCs: 45802-004-02; 45802-004-03; 45802-014-02; 45802-014-05 | Failed Stability Specifications | Perrigo New York / 571,632 tubes | Class II | Terminated |
| D-0851-2018 | 05-07-2018 | SDA Senna Syrup (Sennosides 8.8mg), packaged in 8 FL. OZ. (236 mL) bottles, Distributed by SDA Laboratories 280 Railroad Avenue, Greenwich CT 06830, NDC 66424-562-08, UPC 366424562082 Package NDCs: 66424-562-08; 3664245620 | CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample. | RIJ Pharmaceutical LLC / 3537 bottles | Class II | Terminated |
| D-0863-2018 | 05-04-2018 | Minivelle (estradiol transdermal system) 0.0375 mg/day, 1 System per pouch (NDC 68968-6637-1), packaged in 8 pouches per box (NDC 68968-6637-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186; Dist. by: Noven Therapeutics, LLC, Miami, Florida 33186. Package NDCs: 68968-6625-8; 68968-6637-8; 68968-6650-8; 68968-6675-8; 68968-6610-8; 68968-6637-1 | Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin. | Noven Pharmaceuticals, Inc. / 70870 boxes | Class II | Terminated |
| D-0833-2018 | 05-04-2018 | Zoma Shampoo, Zinc Pyrithione 1.92%, 300 ml/10.01 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT | Subpotent | Milbar Laboratories, Inc. / 1,348 bottles | Class III | Terminated |
