Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-0862-2018 | 05-04-2018 | Minivelle (estradiol transdermal system) 0.1 mg/day, 1 System per pouch (NDC 68968-6610-1), packaged in 8 pouches per box (NDC 68968-6610-8), 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; 68968-6610-1 | 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. / 61960 boxes | 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-0832-2018 | 05-04-2018 | T Shampoo For Hair and Body, Solution Coal Tar 3% (0.6% coal tar), 300 ml/10.1 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT | Subpotent | Milbar Laboratories, Inc. / 952 bottles | Class III | 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 |
| D-0811-2018 | 05-04-2018 | B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%), 200 mL bottles, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA | Microbial Contamination of Non-sterile Product | Milbar Laboratories, Inc. / 3,477 plastic bottles | Class II | Terminated |
| D-0814-2018 | 05-04-2018 | MD Complete Clarifying Cleanser (Salicylic Acid 2.0%), 3 fl oz, (88.7mL), MD Professional LLC, Minneapolis, MN | GMP Deviations | Milbar Laboratories, Inc. / 14,491 tubes | Class II | Terminated |
| D-0813-2018 | 05-04-2018 | Naturmetic SPF 50 Sunscreen (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.0 fl oz/60mL bottles, Fortis BioPharma, Magnolia, TX 77354. | GMP Deviations | Milbar Laboratories, Inc. / 4,815 tubes | Class II | Terminated |
| D-0812-2018 | 05-04-2018 | Solar Defense Sheer Sunscreen Broad Spectrum SPF50 (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.5 FL OZ. 74 mL, Distributed by: BeautyRx LLC, NY, NY 10128 | GMP Deviations | Milbar Laboratories, Inc. / 2,156 tubes | Class II | Terminated |
| D-0823-2018 | 05-01-2018 | Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-903-20. | GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) / 1,152 blister cards of 100 capsules each | Class II | Terminated |
| D-0822-2018 | 05-01-2018 | Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-902-20 | GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) / 1,065 blister cards of 100 capsules each | Class II | Terminated |
| D-0926-2018 | 05-01-2018 | Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intravenous Use Only, Single-Dose vial, Rx Only, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ 05610. NDC 55150-120-30 Package NDCs: 55150-119-30; 55150-120-30; 55150-121-50 | Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass | AuroMedics Pharma LLC / 77,400 vials | Class I | Terminated |
| D-0866-2018 | 05-01-2018 | Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ, NDC 55150-117-20. Package NDCs: 55150-116-20; 55150-117-20; 55150-178-99; 55150-179-99 | Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients. | AuroMedics Pharma LLC / 54,720 vials | Class I | Terminated |
| D-0857-2018 | 04-30-2018 | Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 patch each/ 30 Patches/Carton (NDC 0591-3525-30) Package NDCs: 0591-3525-11; 0591-3525-30 | Failed Stability Specifications | Teva Pharmaceuticals USA / 30,382 patches | Class III | Terminated |
| D-0831-2018 | 04-30-2018 | PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only, 48-count bottle, NDC 00378-4730-22 | CGMP Deviations | Mylan Pharmaceuticals Inc. / 3,844 48-count bottles | Class II | Terminated |
| D-0830-2018 | 04-30-2018 | PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count bottle, NDC 00378-4715-22 | CGMP Deviations | Mylan Pharmaceuticals Inc. / 9,906 48-count bottles | Class II | Terminated |
| D-0829-2018 | 04-30-2018 | PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22 | CGMP Deviations | Mylan Pharmaceuticals Inc. / 7,334 48-count bottles | Class II | Terminated |
| D-0804-2018 | 04-27-2018 | Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business of Sanofi-Aventis U.S. LLC., NDC 0955-1020-01 Package NDCs: 0955-1021-04; 0955-1020-01; 0955-1022-08 | Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed. | Sanofi-Aventis U.S. LLC / 19580 vials | Class II | Terminated |
| D-0801-2018 | 04-26-2018 | Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and non-Aggregated Human Serum Albumin 2.5-5 mg Sodium Acetate Sol 200 mL/0.125 mL lyophilized powder in 10 mL glass vial, Rx only, AnazaoHealth, Tampa, FL | Lack of Assurance of Sterility | Coast Quality Pharmacy LLC / 52 vials | Class II | Terminated |
| D-0818-2018 | 04-26-2018 | Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic bottle, Manufactured by: Mikart, Inc., Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 10631-206-02 Package NDCs: 10631-238-01; 10631-238-02; 10631-206-01; 10631-206-02 | Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature. | Sun Pharmaceutical Industries, Inc. / 19,758 473 mL bottles | Class III | Terminated |
| D-0806-2018 | 04-24-2018 | Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. Mnfct by: Aurolife Pharma LLC, Dayton, NJ 08810. Pckgd by PreScript Pharm Inc. Pleasanton, CA 94566. NDC: 13107-059-99 Bar Code 0078-20-2033 Package NDCs: 13107-058-30; 13107-058-01; 13107-058-05; 13107-058-99; 13107-059-30; 13107-059-01; 13107-059-05; 13107-059-99; 13107-060-30; 13107-060-01; 13107-060-05; 13107-060-99 | Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F). | Prescript Pharmaceuticals, Inc. / 1 20-count containers | Class II | Terminated |
| D-0730-2018 | 04-24-2018 | Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml, sterile injectable, Vitalab Pharmacy, Inc | Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products. | Vitalab Pharmacy, Inc / 22 vials | Class II | Terminated |
| D-0729-2018 | 04-24-2018 | Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc | Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products. | Vitalab Pharmacy, Inc / 2 vials | Class II | Terminated |
| D-0824-2018 | 04-24-2018 | Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01 | CGMP Deviations | Mylan Pharmaceuticals Inc. / 8,679 bottles | Class II | Terminated |
| D-0731-2018 | 04-24-2018 | Methionine 25mg/Inositol 50mg/Choline 50mg/Cyanocobalamin 1mg/ml, Sterile injectable, Vitalab Pharmacy, Inc | Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products. | Vitalab Pharmacy, Inc / 3 vials | Class II | Terminated |
| D-0728-2018 | 04-24-2018 | Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vitalab Pharmacy, Inc | Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products. | Vitalab Pharmacy, Inc / 178 vials | Class II | Terminated |
| D-0733-2018 | 04-24-2018 | Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 10mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 25mcg/mL, sterile injectables, Vitalab Pharmacy, Inc | Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products. | Vitalab Pharmacy, Inc / 60 vials | Class II | Terminated |
| D-0732-2018 | 04-24-2018 | Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable, ST3:Papaverine 40mg/Phentolamine 3mg/Prostaglandin 60mcg/mL, Vitalab Pharmacy, Inc. | Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products. | Vitalab Pharmacy, Inc / N/A | Class II | Terminated |
| D-0825-2018 | 04-24-2018 | Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01 | CGMP Deviations | Mylan Pharmaceuticals Inc. / 11,650 bottles | Class II | Terminated |
| D-0805-2018 | 04-24-2018 | Clindamycin 150 mg capsules, USP, 30-count M-Pak container. Mnfct by: Lannett Co. Inc., Philadelphia, PA. Mnfct for: Lannett Co. Inc., Philadelphia, PA. Pckgd by PreScript Pharm. Inc. Pleasanton, CA 94566. NC 00527-1382-01, Bar Code 0639-30-176 | Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F). | Prescript Pharmaceuticals, Inc. / 50 30-count containers | Class II | Terminated |
| D-0819-2018 | 04-24-2018 | Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01 | cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure | Mylan Pharmaceuticals Inc. / 25,488 bottles | Class II | Terminated |
| D-0809-2018 | 04-24-2018 | Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Mallinckrodt Inc. Hazelwood, MO 63042. Mnfct by:Mallinckrodt Inc. Hazelwood, MO 63042. Pckgd by PreScript Pharm Inc. Pleasanton, CA 94566 NDC: 00406-0484-10 Bar Code 0078-20-1834 | Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F). | Prescript Pharmaceuticals, Inc. / 199 tablets in 20-count containers | Class II | Terminated |
| D-0808-2018 | 04-24-2018 | Clindamycin 300 mg capsules, USP, 28-count M-Pak containers, Rx Only. Mnfct for: Lannett Co. Inc., Philadelphia, PA 19136. Mnfct. by: Lannett Co. Inc., Philadelphia, PA 19136. Pckgd by PreScript Pharm. Inc., Pleasanton, CA 94566. NDC: 00527-1383-01, Bar Code 0784-28-11 | Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F). | Prescript Pharmaceuticals, Inc. / 5 28-count containers | Class II | Terminated |
| D-0820-2018 | 04-24-2018 | Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6899-01 | cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure | Mylan Pharmaceuticals Inc. / 12,924 bottles | Class II | Terminated |
| D-0807-2018 | 04-24-2018 | Chlorhexidine 0.12% liquid, 473 MILLITERS. Rx Only. Mnfct for: XTTRUM Laboratories, Chicago, IL 60609. Mnfct by: pharmaceutical Assoiates, Inc., Greenville, SC 29605. Distrib by: PreScript Pharm. INC., Pleasanton, CA 94588. NDC: 00116-2001-16, Bar Code 1385-38-482 | Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F). | Prescript Pharmaceuticals, Inc. / 24 473-ml bottles | Class II | Terminated |
| D-0715-2018 | 04-23-2018 | Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg, 100-count bottles, Rx Only Mfg. By: Actavis 60 Columbia Rd., Bldg. B Morristown, NJ 07960. NDC 63739-284-10 | Failed Dissolution Specifications. High dissolution results were obtained during stability testing. | Mckesson Packaging Services / 7656 cartons | Class III | Terminated |
| D-0716-2018 | 04-23-2018 | Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles, Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-016-10 | Failed Dissolution Specifications. High dissolution results were obtained during stability testing. | Mckesson Packaging Services / 2966 cartons | Class III | Terminated |
| D-0714-2018 | 04-23-2018 | Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-014-10 | Failed Dissolution Specifications. High dissolution results were obtained during stability testing. | Mckesson Packaging Services / 4266 cartons | Class III | Terminated |
| D-0727-2018 | 04-23-2018 | Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited Bachupally-500 090 India\ NDC 55111-468-01 Package NDCs: 55111-468-30; 55111-468-60; 55111-468-01; 55111-468-05; 55111-468-79; 55111-468-78; 55111-469-30; 55111-469-60; 55111-469-01; 55111-469-05; 55111-469-79; 55111-469-78 | Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count bottle of Metoprolol Succiante Extended-Release Tablets. | Dr. Reddy's Laboratories, Inc. / 8160 bottles | Class II | Terminated |
| D-0826-2018 | 04-20-2018 | Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by: Cipla Ltd., India; For: EAGLE PHARMACEUTICALS, INC., Woodcliff Lake, NJ 07677 USA, NDC 42367-111-06. | Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets. | Exela Pharma Sciences LLC / 5256 bottles | Class II | Terminated |
| D-0802-2018 | 04-19-2018 | Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-count bottle, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St., Philadelphia, PA 19124, Dist, by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 53489-146-05 Package NDCs: 53489-145-01; 53489-145-05; 53489-146-01; 53489-146-05 | Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a foreign matter identified as polyethylene was detected in two (2) tablets. | Sun Pharmaceutical Industries, Inc. / 1,908 500-count bottles | Class II | Terminated |
| D-0710-2018 | 04-17-2018 | Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-count bottle. Marketed by: Rhodes Pharmaceuticals L.P., Coventry, RI 02816. Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834. NDC 42858-402-45 | Failed Dissolution Specification: Low dissolution outside of specifications | Rhodes Pharmaceuticals, L.P. / 2454 bottles | Class III | Terminated |
| D-0288-2019 | 04-16-2018 | Euphoric Premium Male Performance Enhancer capsules, packaged in a)1-count blister cards, UPC 6 96859 28646 9, b) 3-count bottle, UPC 6 96859 28647 6 and c) 12-count bottle, UPC 6 96859 28648 3. | Marketed Without An Approved NDA/ANDA: product contains undeclared sildenafil, tadalafil, and oxytetracycline, FDA approved drug products making Euphoric an unapproved drug. | Epic Products, LLC / a) 106,329 cards; b) 109,725 bottles; c) 28,644 bottles | Class I | Terminated |
| D-0711-2018 | 04-13-2018 | Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) 118.28 mL (4 fl. oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-331-04, UPC 364980331043 Package NDCs: 64980-331-04; 3649803310 | Subpotent Drug | Lyne Laboratories, Inc. / 12572 units | Class II | Terminated |
| D-0712-2018 | 04-13-2018 | Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-329-20, UPC 364980329200 Package NDCs: 64980-329-20; 3649803292 | Subpotent Drug | Lyne Laboratories, Inc. / 17939 units | Class II | Terminated |
| D-0713-2018 | 04-13-2018 | Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) 118.28 mL (4 fl.oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-330-04, UPC 364980330046 Package NDCs: 64980-330-04; 3649803300 | Subpotent Drug | Lyne Laboratories, Inc. / 23453 units | Class II | Terminated |
| D-0828-2018 | 04-13-2018 | OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box of 10 cartridges of 0.4mg/1.7mL each, Rx only, Distributed by Septodont, Inc., Louisville, CO 80027, Made in Canada by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0101-10 Package NDCs: 0362-0101-10 | Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS) result that was obtained for related substance (Phentolamide), a known degradation product impurity at the 15 month stability test point. | Septodont Inc. / 8509 boxes | Class III | Terminated |
| D-0803-2018 | 04-13-2018 | Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA | Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement of ingredients misstates the concentration of active ingredient at 7%. The primary packaging (tube) correctly states the active ingredient at 10%. | Boiron Inc. / 52,810 tubes | Class III | Terminated |
| D-0821-2018 | 04-12-2018 | Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack, Distributed by AMA Wholesale Inc. Chino Hills, CA, 91709-2618, UPC Code: 718122071128 | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared tadalafil. The presence of tadalafil makes Rhino Extreme 50000 an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. | AMA Wholesale / unknown | Class I | Terminated |
| D-0702-2018 | 04-11-2018 | NEOstigmine Methylsulfate (1 mg/mL) 3mg per 3mL. 3mL Single Dose Syringe. Premier Pharmacy Labs. 8265 Commercial Way Weeki Wachee, FL 34613 NDC 69623-234-14. | Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products. | Premier Pharmacy Labs Inc / 600 syringes | Class II | Terminated |
| D-0699-2018 | 04-11-2018 | Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613. NDC 69623-129-10 | Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products. | Premier Pharmacy Labs Inc / 4555 syringes | Class II | Terminated |
| D-0700-2018 | 04-11-2018 | Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613. NDC 69623-127-10 | Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products. | Premier Pharmacy Labs Inc / 4192 syringes | Class II | Terminated |
| D-0701-2018 | 04-11-2018 | Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile Single-Dose Syringe. 8265 Commercial Way Weeki Wachee, FL 34613 NDC 69623-249-10 | Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products. | Premier Pharmacy Labs Inc / 3570 syringes | Class II | Terminated |
| D-0815-2018 | 04-10-2018 | Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 count), NDC 45567-0455-1 and (30 count), NDC 45567-0455-2 . Manufactured by: Pharmalucence, Inc., Billerica, MA 01821. Package NDCs: 45567-0455-1; 45567-0455-2 | Failed Stability Specifications | Pharmalucence, Inc. / 157 units (5 count) and 464 units (30 count) | Class II | Terminated |
| D-0632-2018 | 04-10-2018 | Vasopressin 50 Units added to 250 mL 0.9% Sodium Chloride Injection USP (0.2 units per mL), Rx only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 | cGMP deviations | Pharmedium Services, LLC / 72 bags | Class III | Terminated |
| D-0810-2018 | 04-10-2018 | Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00 | Presence of Foreign Tablets/Capsules | Aidarex Pharmaceuticals LLC / 450 bottles | Class III | Terminated |
| D-0683-2018 | 04-09-2018 | Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc. Amityville, NY 11701 for Leadiant Biosciences, Inc. Gaithersburg, MD 20878, NDC 54482-020-01 Package NDCs: 54482-020-01; 54482-020-02; 54482-035-02 | Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride. | LEADIANT BIOSCIENCES, INC / 3,398 bottles | Class III | Terminated |
| D-0627-2018 | 04-09-2018 | Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches Rx Only NDC 68968-5552-3 Manufactured for Noven Therapeutics, LLC., Miami, FL 33186 by Noven Pharmaceuticals, Inc. Miami, FL 33186 1-877-567-7857 Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of specification for adhesive transfer. | Noven Pharmaceuticals, Inc. / 9016 boxes of 30 patch each | Class II | Terminated |
| D-0631-2018 | 04-06-2018 | Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles, Rx only, Manufactured by Sandoz, Inc., Princeton, NJ 08540, NDC 0781-5067-05. | Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous). | Sandoz Incorporated / 11,680 bottles | Class III | Terminated |
| D-0725-2018 | 04-05-2018 | METHYLCOBALAMIN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 | Presence of Particulate matter. Recall due to presence of unknown particulate matter. | Coastal Meds, LLC. / 4524 vials | Class II | Terminated |
| D-0721-2018 | 04-05-2018 | LIPO-DEN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 | Presence of Particulate matter. Recall due to presence of unknown particulate matter. | Coastal Meds, LLC. / 1309 vials | Class II | Terminated |
| D-0719-2018 | 04-05-2018 | HYDROXOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 | Presence of Particulate matter. Recall due to presence of unknown particulate matter. | Coastal Meds, LLC. / 1506 vials | Class II | Terminated |
| D-0720-2018 | 04-05-2018 | LIPO-B Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 | Presence of Particulate matter. Recall due to presence of unknown particulate matter. | Coastal Meds, LLC. / 3959 vials | Class II | Terminated |
| D-0717-2018 | 04-05-2018 | CYANOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 | Presence of Particulate matter. Recall due to presence of unknown particulate matter. | Coastal Meds, LLC. / 745 vials | Class II | Terminated |
| D-0724-2018 | 04-05-2018 | LIPO-PLEX Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 | Presence of Particulate matter. Recall due to presence of unknown particulate matter. | Coastal Meds, LLC. / 8099 vials | Class II | Terminated |
| D-0718-2018 | 04-05-2018 | ADENO-PLEX Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 | Presence of Particulate matter. Recall due to presence of unknown particulate matter. | Coastal Meds, LLC. / 200 vials | Class II | Terminated |
| D-0723-2018 | 04-05-2018 | LIPO-DEN PLUS Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 | Presence of Particulate matter. Recall due to presence of unknown particulate matter. | Coastal Meds, LLC. / 1457 vials | Class II | Terminated |
| D-0722-2018 | 04-05-2018 | LIPO-DEN EXTREME Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 | Presence of Particulate matter. Recall due to presence of unknown particulate matter. | Coastal Meds, LLC. / 3733 vials | Class II | Terminated |
| D-0726-2018 | 04-05-2018 | PYRIDOXINE Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 | Presence of Particulate matter. Recall due to presence of unknown particulate matter. | Coastal Meds, LLC. / 635 vials | Class II | Terminated |
| D-0780-2018 | 04-03-2018 | Temozolomide 20 mg NDC 43975-0253-05 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0770-2018 | 04-03-2018 | Promacta 50 mg tablet NDC 00078-0686-15 30 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0755-2018 | 04-03-2018 | Creon DR 24,000 Units Capsule #250 NDC 00032-1224-07 30 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
