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-0045-2019 | 08-03-2018 | Premier Value, Nasal Decongestant, No Drip Nasal Spray (oxymetazoline HCl) Nasal Solution, 12 Hour Pump Mist, Maximum Strength, 1 FL OZ (30 mL) bottle, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-308-03, UPC 8 40986 01519 9. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 9024 bottles | Class II | Terminated |
| D-0054-2019 | 08-03-2018 | TopCare, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14 g) tube, Distributed By Topco Associates LLC, Elk Grove Village, IL 60007, UPC 0 36800 42146 2. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 7,488 tubes | Class II | Terminated |
| D-0051-2019 | 08-03-2018 | Rite Aid Pharmacy, nasal relief NO DRIP PUMP SPRAY nasal spray, (oxymetazoline hydrochloride 0.05%), 12 Hour, 1 FL OZ (30 mL) bottle, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, UPC 0 11822 31412 1. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 114,336 bottles | Class II | Terminated |
| D-0079-2019 | 08-03-2018 | Finafta Baby, Oral Gel (benzocaine 7.5%), 7.1 Grams (0.25 Oz.) tube, Distributed By: Efficient Laboratories, Inc., Miami, FL 33166. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / Unknown | Class II | Terminated |
| D-0068-2019 | 08-03-2018 | Premier Value, Fast Relief, Muscle Rub, (menthol 10% and methyl salicylate 15%) 4 OZ (113 g) tube, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd., Suite 101, Boca Raton, FL, 33431, UPC 8 40986 01341 | Superpotent Drug: high out of specification assay results for the menthol ingredient. | Product Quest Manufacturing LLC / 4,692 tubes | Class II | Terminated |
| D-0048-2019 | 08-03-2018 | Premier Value, Saline Nasal Spray, Sodium Chloride 0.65%, packaged as a) 3 FL OZ (88 mL) bottle NDC 68016-388-00 UPC 8 40986 01483 3; b) 1.5 FL OZ (44 mL) bottle NDC 68016-466-00 UPC 8 40986 01482 6, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 102,348 bottles | Class II | Terminated |
| D-1179-2018 | 08-03-2018 | Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 & 1/2 grain (90 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-157-04. | Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled. | Westminster Pharmaceuticals LLC / Unknown | Class I | Terminated |
| D-1181-2018 | 08-03-2018 | Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/4 grain (15 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-159-04. | Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled. | Westminster Pharmaceuticals LLC / Unknown | Class I | Terminated |
| D-1180-2018 | 08-03-2018 | Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/2 grain (30 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-155-04. | Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled. | Westminster Pharmaceuticals LLC / Unknown | Class I | Terminated |
| D-1182-2018 | 08-03-2018 | Levothyroxine and Liothyronine (Thyroid Tablets, USP), 2 grain (120 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-158-04. | Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled. | Westminster Pharmaceuticals LLC / Unknown | Class I | Terminated |
| D-1178-2018 | 08-03-2018 | Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 grain (60 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-156-04. | Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled. | Westminster Pharmaceuticals LLC / Unknown | Class I | Terminated |
| D-0074-2019 | 08-03-2018 | Sinus Relief (oxymetazoline HCl) Nasal decongestant, 0.05%, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 43236 5. | Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa. | Product Quest Manufacturing LLC / 16 bottles | Class I | Terminated |
| D-0032-2019 | 08-03-2018 | CVS Health, Sterile Saline Nasal Mist (sodium chloride) Allergy & Sinus Relief, 3.0%, 4.25 OZ (126 g) can, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 41854 3. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 277,587 cans | Class II | Terminated |
| D-0031-2019 | 08-03-2018 | CVS Health, Saline Nasal Spray, Nasal Moisturizing Spray, Contains: Sodium Chloride 0.65%, Benzyl Alcohol & Benzalkonium Chloride as Preservatives, 1.5 FL OZ (44 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 40814 8 Product #891465. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 552 bottles | Class II | Terminated |
| D-0067-2019 | 08-03-2018 | Rite Aid Pharmacy, First Aid Antibiotic Ointment, (neomycin sulfate 3.5 mg, polymyxin B sulfate 5,000 units, bacitracin zinc 400 units per gram), 2 OZ (56 g) tube, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, UPC 0 11822 55441 1. | Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient. | Product Quest Manufacturing LLC / 5,004 tubes | Class II | Terminated |
| D-0027-2019 | 08-03-2018 | DERMATONE (titanium oxide 6% and zinc oxide 4.7%) No-Touch Sunscreen Stick, SPF 50, Net Wt. 0.49 oz. (13.9g) stick, Distributed by: Beaumont Products, Inc. Kennesaw, GA 30144, UPC 0 20908 05100 3. | Microbial Contamination of Non-Sterile Products: sample tested positive for Staphylococcus aureus. | Product Quest Manufacturing LLC / 5025 sticks | Class II | Terminated |
| D-0059-2019 | 08-03-2018 | Best Choice, SALINE Nasal Spray (Sodium Chloride 0.65% Phenylcarbinol & Benzalkonium Chloride as Preservatives), 1.5 FL OZ (44 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC 0 70038 58487 2. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 30,096 bottles | Class II | Terminated |
| D-0058-2019 | 08-03-2018 | Best Choice, 12 Hour No-Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) Nasal Decongestant, 1 FL OZ (30 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC 0 70038 59895 4. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 3,600 bottles | Class II | Terminated |
| D-0066-2019 | 08-03-2018 | FREEZE IT (camphor 0.2% and menthol 3.5%) spray, 118.29 mL (4 fl. oz.) can, Distributed by: Expedite Products, Inc., Tampa, FL 33619 USA, UPC 8 56569 00203 6. | Superpotent Drug: high out of specification assay results for the camphor ingredient. | Product Quest Manufacturing LLC / 6,109 cans | Class II | Terminated |
| D-0042-2019 | 08-03-2018 | Meijer, Sterile Saline Nasal Mist (0.9% Sodium Chloride Solution), 4.25 OZ (120 g) can, Dist. By Meijer Distribution, Inc., 2929 Walker Ave. NW, Grand Rapids, MI 49544, UPC 7 13733 27615 3. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 37,464 cans | Class II | Terminated |
| D-0060-2019 | 08-03-2018 | Walgreens, Nasal Spray (Oxymetazoline HCl 0.05%) Nasal Decongestant, Maximum Strength, 12 Hour, 0.75 FL OZ (22 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015, UPC 3 11917 18622 1. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 141,888 bottles | Class II | Terminated |
| D-0040-2019 | 08-03-2018 | Harmon Face Values, Saline Nasal Spray (sodium chloride), 0.65%, packaged as a) 1.5 FL OZ (44 mL) bottle UPC 7 27510 00501 0; b) 3 FL OZ (88 mL) bottle UPC 7 27510 00502 7, Distributed by Harmon Stores, Inc., Union, NJ 07083 USA. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 39,924 bottles | Class II | Terminated |
| D-1079-2018 | 08-02-2018 | Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 India, NDC 55111-123-05 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 - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets. | Dr. Reddy's Laboratories, Inc. / 2280 bottles | Class III | Terminated |
| D-1149-2018 | 08-02-2018 | Human Chorionic Gonadotropin 20000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009 | Lack of assurance of sterility. | Pharmcore Inc. / 355 vials | Class II | Terminated |
| D-1150-2018 | 08-02-2018 | Human Chorionic Gonadotropin 2500 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009 | Lack of assurance of sterility. | Pharmcore Inc. / 3070 vials | Class II | Terminated |
| D-1154-2018 | 08-02-2018 | Methylcobalamin 10 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009 | Lack of assurance of sterility. | Pharmcore Inc. / 1115 vials | Class II | Terminated |
| D-1151-2018 | 08-02-2018 | Human Chorionic Gonadotropin 4000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009 | Lack of assurance of sterility. | Pharmcore Inc. / 2085 vials | Class II | Terminated |
| D-1147-2018 | 08-02-2018 | Human Chorionic Gonadotropin 5000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009 | Lack of assurance of sterility. | Pharmcore Inc. / 5718 vials | Class II | Terminated |
| D-1153-2018 | 08-02-2018 | Ipamorelin 3 mg Lyophilized 1 vial 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009 | Lack of assurance of sterility. | Pharmcore Inc. / 6 vials | Class II | Terminated |
| D-1155-2018 | 08-02-2018 | Ipamorelin 9 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009 | Lack of assurance of sterility. | Pharmcore Inc. / 599 vials | Class II | Terminated |
| D-1148-2018 | 08-02-2018 | Human Chorionic Gonadotropin 11000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009 | Lack of assurance of sterility. | Pharmcore Inc. / 864 vials | Class II | Terminated |
| D-1152-2018 | 08-02-2018 | Human Chorionic Gonadotropin 6000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009 | Lack of assurance of sterility. | Pharmcore Inc. / 3351 vials | Class II | Terminated |
| D-1582-2019 | 08-01-2018 | Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217, NDC Carton: 62584-693-21; NDC Unit Dose: 62584-693-11 Package NDCs: 62584-693-11; 62584-693-21 | Failed Dissolution Specifications: Out of specification result for the dissolution test. | American Health Packaging / 6,579 cartons | Class II | Terminated |
| D-1035-2018 | 08-01-2018 | Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 100 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-047-24. Package NDCs: 36000-045-01; 36000-046-24; 36000-047-24; 36000-048-24 | Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution. | Baxter Healthcare Corporation / 106,320 bags | Class III | Terminated |
| D-1036-2018 | 08-01-2018 | Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose, 150 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-048-24. Package NDCs: 36000-045-01; 36000-046-24; 36000-047-24; 36000-048-24 | Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution. | Baxter Healthcare Corporation / 711,216 bags | Class III | Terminated |
| D-1046-2018 | 08-01-2018 | Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-667-30 | Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months. | Akorn, Inc. / 22,605 tubes | Class II | Terminated |
| D-1034-2018 | 08-01-2018 | Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-046-24. Package NDCs: 36000-045-01; 36000-046-24; 36000-047-24; 36000-048-24 | Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution. | Baxter Healthcare Corporation / 191,256 bags | Class III | Terminated |
| D-1026-2018 | 07-30-2018 | Doxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit dose Cartons, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NY 07724; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-0430-04 Package NDCs: 0904-0430-95; 0904-0430-04; 0904-0430-06 | Failed Dissolution Specifications | MAJOR PHARMACEUTICALS / 3,161 Cartons | Class II | Terminated |
| D-1037-2018 | 07-30-2018 | Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4311-9 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | NuCare Pharmaceuticals Inc / N/A | Class II | Terminated |
| D-1039-2018 | 07-30-2018 | Valsartan/HCTZ 320/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4183-3 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | NuCare Pharmaceuticals Inc / N/A | Class II | Terminated |
| D-1038-2018 | 07-30-2018 | Valsartan/HCTZ 160/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | NuCare Pharmaceuticals Inc / N/A | Class II | Terminated |
| D-1029-2018 | 07-27-2018 | Valsartan 320 mg tablets, 90-count bottles ( NDC 71335-0567-2), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504. Package NDCs: 71335-0567-1; 71335-0567-2; 71335-0567-3; 71335-0567-4 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Bryant Ranch Prepack Inc. / 90 tablets | Class II | Terminated |
| D-1027-2018 | 07-27-2018 | Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-count bottles (63629-6922-4), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504. | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Bryant Ranch Prepack Inc. / 690 tablets | Class II | Terminated |
| D-1028-2018 | 07-27-2018 | Valsartan 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bottles (NDC 63629-6905-2), 28-count bottles (NDC 6362-96905-3), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504. | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Bryant Ranch Prepack Inc. / 990 tablets | Class II | Terminated |
| D-1047-2018 | 07-26-2018 | Testosterone 200 mg Pellet, Rx only, Carie Boyd's Prescription Shop 122 Grapevine Hwy., Hurst, TX 76054, 800-930-4361 | Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect expiration date on label | Right Value Drug Stores, Inc. / 4800 pellets | Class III | Terminated |
| D-1022-2018 | 07-26-2018 | Valsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkins Co, Inc. Grover Beach, CA 93433, NDC 43547-0369-09. Tablet is yellow, capsule-shaped, biconvex, film-coated tablets debossed with 343 on one side and HH on the other side. | Carcinogen impurity detected in API used to manufacture drug product. | H J Harkins Company Inc dba Pharma Pac / 540 tablets | Class II | Terminated |
| D-1050-2018 | 07-26-2018 | Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01 Package NDCs: 68180-422-01 | Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study. | Lupin Pharmaceuticals Inc. / 13,896 bottles | Class III | Terminated |
| D-1075-2018 | 07-25-2018 | Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg / 50 mcg per spray, packaged in a 23 g net fill weight, Rx only, Manufactured by: Cipla Ltd., Goa, India, M.L.,, NDC 0037-0245-23 Package NDCs: 0037-0245-23 | Presence of foreign substance: Potential for glass in the neck area of the glass bottles. | Mylan Pharmaceuticals Inc. / 20,780 bottles | Class II | Terminated |
| D-1091-2018 | 07-25-2018 | PRASH 12.2mcg/1.22m/19.29 (Prostaglandin/Phentolamine/Papaverine) Injection, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644. | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. | Ranier's Compounding Laboratory / 1 vial | Class II | Terminated |
| D-1082-2018 | 07-25-2018 | Avastin 1.25 mg/0.05 mL prefilled syringe, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644. | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. | Ranier's Compounding Laboratory / 213 prefilled syringes | Class II | Terminated |
| D-1078-2018 | 07-25-2018 | alba BOTANICA Sensitive Sheer Shield Sunscreen Fragrance Free spf 50+ , 85 g 3 oz tube. Manufactured by: The Haine Celestial Group, Inc. Lake Success, NY, UPC 7 24742 00438 5 | Microbial Contamination of a Non-Sterile Product | The Hain Celestial Group, Inc. - Worldwide HQ / 1,098 tubes | Class II | Terminated |
| D-1080-2018 | 07-25-2018 | Atropine 0.01% Opth Solution, 5 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644. | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. | Ranier's Compounding Laboratory / 5 droptainers | Class II | Terminated |
| D-1092-2018 | 07-25-2018 | PRO/PA/PH/AT 18mcg/1.8mg/ (Prostaglandin//Papaverine/Phentolamine/Atropine) Injection, 18mcg/1.8 mg/0.2 mg/0.02 mg/mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644. | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. | Ranier's Compounding Laboratory / 1 vial | Class II | Terminated |
| D-1094-2018 | 07-25-2018 | Papav 300/Phent 5mg/10mL (Papaverine/Phentolamine) Injection,300 mg/5 mg/10 mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644. | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. | Ranier's Compounding Laboratory / 2 vials | Class II | Terminated |
| D-1089-2018 | 07-25-2018 | Acetylcysteine 10% Oph Solution, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644. | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. | Ranier's Compounding Laboratory / 1 droptainer | Class II | Terminated |
| D-1085-2018 | 07-25-2018 | Morphine Sulf inhalation, 5mg/3cc, 3cc per vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644. | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. | Ranier's Compounding Laboratory / 60 vials | Class II | Terminated |
| D-1093-2018 | 07-25-2018 | P/P/P 0.02/40/2mg/mL(Prostaglandin//Papaverine/Phentolamine) Injection, 0.02/40/2 mg/mL, 1 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644. | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. | Ranier's Compounding Laboratory / 1 vial | Class II | Terminated |
| D-1087-2018 | 07-25-2018 | Vitamin D3 Injection, 50,000 IU/mL, 4 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644. | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. | Ranier's Compounding Laboratory / 2 vials | Class II | Terminated |
| D-1083-2018 | 07-25-2018 | Triple P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.008/22.5/0.83 mg/mL, packaged in a) 5 mL and b) 10 mL vials, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644. | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. | Ranier's Compounding Laboratory / a) 1 vial; b) 1 vial | Class II | Terminated |
| D-1084-2018 | 07-25-2018 | PR/PA/PH (Prostaglandin/Papaverine/Phentolamine) Injection, 10mcg/30/1mg/mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644. | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. | Ranier's Compounding Laboratory / 1 vial | Class II | Terminated |
| D-1081-2018 | 07-25-2018 | DMSO 6.25% Opth Sol, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644. | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. | Ranier's Compounding Laboratory / 1 droptainer | Class II | Terminated |
| D-1088-2018 | 07-25-2018 | Medroxprogesterone 1% Ophthalmic Solution, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644. | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. | Ranier's Compounding Laboratory / 1 droptainer | Class II | Terminated |
| D-1086-2018 | 07-25-2018 | Dehydrated Alcohol Solution, packaged in a) 1 mL and b) 3 mL vials, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644. | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. | Ranier's Compounding Laboratory / a) 2 vials; b) 1 vial | Class II | Terminated |
| D-1090-2018 | 07-25-2018 | P/P/P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.02/30/2 mg/mL, 5 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644. | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. | Ranier's Compounding Laboratory / 2 vials | Class II | Terminated |
| D-1025-2018 | 07-24-2018 | Doxycycline Hyclate Tablets, USP, 100 mg*. 500-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-05. Package NDCs: 0143-2112-50; 0143-2112-05; 0143-2112-20 | Failed Dissolution Specifications: | West-Ward Columbus Inc / 29048 500-count bottles (14,524,000 tablets) | Class II | Terminated |
| D-1024-2018 | 07-24-2018 | Doxycycline Hyclate Tablets, USP, 100 mg*. 50-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-50. Package NDCs: 0143-2112-50; 0143-2112-05; 0143-2112-20 | Failed Dissolution Specifications: | West-Ward Columbus Inc / 29,048 bottles (1,452,400 tablets) | Class II | Terminated |
| D-1042-2018 | 07-24-2018 | Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, 8 fl oz (237 mL) Bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-212-08. | Defective Container: Tamper Evident foil seal not completely intact. | Morton Grove Pharmaceuticals, Inc. / 38,280 bottles | Class II | Terminated |
| D-1044-2018 | 07-24-2018 | 5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in 5 mL BD Syringe Kit Check Tagged, PharMEDium Services, LLC. | CGMP deviations: Product was released while a hood certification discrepancy was being investigated. | PharMEDium Services, LLC / 450 Syringes | Class II | Terminated |
| D-1045-2018 | 07-24-2018 | 10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium Services, LLC. | CGMP deviations: Product was released while a hood certification discrepancy was being investigated. | PharMEDium Services, LLC / 575 Syringes | Class II | Terminated |
| D-1043-2018 | 07-24-2018 | 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag and 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag, PharMEDium Services, LLC. | CGMP deviations: Product was released while a hood certification discrepancy was being investigated. | PharMEDium Services, LLC / 230 Intravia Bags | Class II | Terminated |
| D-0738-2019 | 07-20-2018 | Dr. King's SafeCare Rx Acute Viro Reliever, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955008125, NDC 57955-0432-2 | Microbial contamination | King Bio Inc. / 1530 bottles | Class I | Terminated |
| D-0842-2019 | 07-20-2018 | Dr. King's SafeCare Rx AddictaPlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955300021, NDC 57955-3003-2 | Microbial contamination | King Bio Inc. / 102 bottles | Class I | Terminated |
| D-0565-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Weather Changes, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955528722, NDC 57955-5287-2 | Microbial contamination | King Bio Inc. / 158 bottles | Class I | Terminated |
| D-0763-2019 | 07-20-2018 | Dr. King's SafeCare Rx Chronic Viro Reliever U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955008828, NDC 57955-0103-2 | Microbial contamination | King Bio Inc. / 1002 bottles | Class I | Terminated |
| D-0744-2019 | 07-20-2018 | Dr. King's SafeCare Rx Heart Regularity Circulation, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955006527, NDC 57955-0065-2 | Microbial contamination | King Bio Inc. / 386 bottles | Class I | Terminated |
| D-0659-2019 | 07-20-2018 | Dr. King's Kids Bed Wetting Homeopathic, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955501220, NDC 57955-0447-2 | Microbial contamination | King Bio Inc. / 600 bottles | Class I | Terminated |
| D-0909-2019 | 07-20-2018 | Dr. King's Safecare+ AsthmaCare Homeopathic, Not a Rescue Inhaler, 2 fl oz (59 mL), UPC 357955404422, NDC 57955-4044-1 | Microbial contamination | King Bio Inc. / 190189 bottles | Class I | Terminated |
| D-0792-2019 | 07-20-2018 | Dr. King's SafeCare Rx Artery/Cholesterol/BP, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955006428, NDC 57955-0064-2 | Microbial contamination | King Bio Inc. / 544 bottles | Class I | Terminated |
| D-0617-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Dust Mite & Roach Allergy Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955519720, NDC 57955-6497-2 | Microbial contamination | King Bio Inc. / 146 bottles | Class I | Terminated |
| D-0713-2019 | 07-20-2018 | Dr. King's SafeCare Rx Stress Control Mind & Body, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955185024, NDC 57955-1852-2 | Microbial contamination | King Bio Inc. / 2644 bottles | Class I | Terminated |
| D-0758-2019 | 07-20-2018 | Dr. King's SafeCare Rx Chagrined, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955204022, NDC 57955-2041-2 | Microbial contamination | King Bio Inc. / 14 bottles | Class I | Terminated |
| D-0775-2019 | 07-20-2018 | Dr. King's SafeCare Rx CS-Bone, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955021124, NDC 57955-0211-2 | Microbial contamination | King Bio Inc. / 18 bottles | Class I | Terminated |
| D-0552-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic 9-1-1 Burnout, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955597926, NDC 57955-5979-2 | Microbial contamination | King Bio Inc. / 2898 bottles | Class I | Terminated |
| D-0542-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Gallbladder Formula, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955506829, NDC 57955-6058-2 | Microbial contamination | King Bio Inc. / 1735 bottles | Class I | Terminated |
| D-0680-2019 | 07-20-2018 | Dr. King's SafeCare Rx Lonely Mind & Body High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville, NC 28806 USA, UPC 357955200024, NDC 57955-2001-2 | Microbial contamination | King Bio Inc. / 53 bottles | Class I | Terminated |
| D-0556-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Anxiety & Nervousness, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955516323, NDC 57955-5163-2 | Microbial contamination | King Bio Inc. / 21925 bottles | Class I | Terminated |
| D-0632-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Dental Plak, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955887027, NDC 57955-1904-2 | Microbial contamination | King Bio Inc. / 16 bottles | Class I | Terminated |
| D-0798-2019 | 07-20-2018 | Dr. King's SafeCare Rx Grief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955206026, NDC 57955-2061-2 | Microbial contamination | King Bio Inc. / 600 bottles | Class I | Terminated |
| D-0562-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Animal Hair & Dander Allergy Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955519621, NDC 57955-6490-2 | Microbial contamination | King Bio Inc. / 367 bottles | Class I | Terminated |
| D-0604-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Multi-Strain Flu Relief, 2 fl. oz. (59 mL), King Bio, Inc. 3 Westside Dr. Asheville, NC 28806, UPC 357955519928, NDC 57955-5194-2 | Microbial contamination | King Bio Inc. / 10025 bottles | Class I | Terminated |
| D-0682-2019 | 07-20-2018 | Dr. King's SafeCare Rx Children's Appetite & Weight Control Children High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955251729, NDC 57955-2518-2 | Microbial contamination | King Bio Inc. / 3 bottles | Class I | Terminated |
| D-0699-2019 | 07-20-2018 | Dr. King's Natural Medicine Soothing Advanced Arnica Pure Homeopathic Cream, 3 oz. (85 g), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955400035, NDC 57955-4000-3 | Microbial contamination | King Bio Inc. / 17527 tubes | Class I | Terminated |
| D-0900-2019 | 07-20-2018 | Aquaflora High Potency Candida Control Program Homeopathic Formula, Net 16 fl. oz. (1 pt) 473 mL, Manufactured by: King Bio, Inc. 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955160366, NDC 57955-1603-6 | Microbial contamination | King Bio Inc. / 5000 bottles | Class I | Terminated |
| D-0879-2019 | 07-20-2018 | Dr. King's SafeCare Rx Allergies: Nightshades, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955250029, NDC 57955-2502-2 | Microbial contamination | King Bio Inc. / 45 bottles | Class I | Terminated |
| D-0686-2019 | 07-20-2018 | Dr. King's SafeCare Rx Newborn Tonic Children High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville, NC 28806 USA, UPC 357955011422, NDC 57955-0114-2 | Microbial contamination | King Bio Inc. / 15 bottles | Class I | Terminated |
| D-0804-2019 | 07-20-2018 | Dr. King's SafeCare Rx Indigestion Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955002420, NDC 57955-0024-2 | Microbial contamination | King Bio Inc. / 194 bottles | Class I | Terminated |
| D-0952-2019 | 07-20-2018 | NET Remedies #11 Visceral Polarity Homeopathic Preparation, Oral Liquid, 57 mL, NDC 57955-4211-2 | Microbial contamination | King Bio Inc. / 14695 bottles | Class I | Terminated |
| D-0675-2019 | 07-20-2018 | Dr. King's Natural Medicine for kids! Children's Appetite & Weight Homeopathic, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville, NC 28806 USA, UPC 357955551720, NDC 57955-6017-2 | Microbial contamination | King Bio Inc. / 149 bottles | Class I | Terminated |
| D-0955-2019 | 07-20-2018 | NET Remedies #25 Yin/Yang Balance Homeopathic Preparation, Oral Liquid, 57 mL, NDC 57955-4215-2 | Microbial contamination | King Bio Inc. / 5092 bottles | Class I | Terminated |
| D-0854-2019 | 07-20-2018 | Dr. King's SafeCare Rx Heartache, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955203025, NDC 57955-2030-2 | Microbial contamination | King Bio Inc. / 153 bottles | Class I | Terminated |
