Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 08, 2025 and include a total of 16999 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0452-2017 | 12-28-2016 | Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India Package NDCs: 55111-143-30; 55111-143-01; 55111-143-05; 55111-143-79; 55111-143-78; 55111-144-30; 55111-144-01; 55111-144-05; 55111-144-79; 55111-144-78; 55111-145-71; 55111-145-12; 55111-146-30; 55111-146-01; 55111-146-05; 55111-146-79; 55111-146-78 | Failed Dissolution Specifications; 18 month stability time point | Dr. Reddy's Laboratories, Inc. / a) 38,832 and b) 5,064 bottles | Class II | Terminated |
| D-0451-2017 | 12-28-2016 | Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India --- NDC 55111-145-12 Package NDCs: 55111-143-30; 55111-143-01; 55111-143-05; 55111-143-79; 55111-143-78; 55111-144-30; 55111-144-01; 55111-144-05; 55111-144-79; 55111-144-78; 55111-145-71; 55111-145-12; 55111-146-30; 55111-146-01; 55111-146-05; 55111-146-79; 55111-146-78 | Failed Dissolution Specifications; 18 month stability time point | Dr. Reddy's Laboratories, Inc. / 59,440 blister cards | Class II | Terminated |
| D-0449-2017 | 12-28-2016 | Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 count (NDC 55111-143-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India Package NDCs: 55111-143-30; 55111-143-01; 55111-143-05; 55111-143-79; 55111-143-78; 55111-144-30; 55111-144-01; 55111-144-05; 55111-144-79; 55111-144-78; 55111-145-71; 55111-145-12; 55111-146-30; 55111-146-01; 55111-146-05; 55111-146-79; 55111-146-78 | Failed Dissolution Specifications; 18 month stability time point | Dr. Reddy's Laboratories, Inc. / a) 2472 bottles, b) 780 bottles | Class II | Terminated |
| D-0434-2017 | 12-28-2016 | Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, 45 g tubes, Rx Only, Manufactured by Perrigo, Yeruham, Israel, Distributed by Perrigo, Allegan, MI --- NDC 45802-736-84, UPC 345802736840 Package NDCs: 45802-736-84; 3458027368 | Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap | L. Perrigo Company / 162,534 tubes | Class II | Terminated |
| D-0692-2017 | 12-27-2016 | Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada, Distributed by Major Pharmaceuticals, Livonia, MI NDC 0904-6509-04 | Superpotent Drug; out of specification results for assay (manufacturer) | The Harvard Drug Group / 36,990 tablets | Class III | Terminated |
| D-0437-2017 | 12-22-2016 | Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31. Package NDCs: 0054-4297-31; 0054-4297-25; 0054-8297-25; 0054-4299-31; 0054-4299-25; 0054-8299-25; 0054-4301-29; 0054-4301-25; 0054-8301-25; 0054-3298-63; 0054-3294-50; 0054-3294-46 | Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint. | Roxane Laboratories, Inc. / 6493 bottles | Class II | Terminated |
| D-0236-2017 | 12-22-2016 | Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10 | Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%) | Sandoz Incorporated / 96 bottles | Class II | Terminated |
| D-0474-2017 | 12-22-2016 | Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 072 India, NDC 65862-527-30 Package NDCs: 65862-527-47; 65862-527-30; 65862-527-90; 65862-527-01; 65862-527-99; 65862-527-59; 65862-527-10; 65862-528-47; 65862-528-30; 65862-528-90; 65862-528-01; 65862-528-99; 65862-528-35; 65862-528-10; 65862-697-47; 65862-697-30; 65862-697-90; 65862-697-01; 65862-697-05; 65862-697-26; 65862-697-10 | Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules. | Aurobindo Pharma USA Inc / 47,040 bottles | Class II | Terminated |
| D-0326-2017 | 12-22-2016 | TEMAZEPAM CAPSULES USP, 7.5 mg, 100 count bottles, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-5891-21 | Failed Stability Specifications | Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals / 1200 bottles | Class III | Terminated |
| D-0440-2017 | 12-21-2016 | Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4150-73 | Subpotency: due to a low, out of specification test result for assay during stability testing. | Teva Pharmaceuticals USA / 133,601 bottles | Class II | Terminated |
| D-0478-2017 | 12-20-2016 | Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-376-17 | Failed tablet/capsule specification: missing break line on the 5mg tablet. | Accord Healthcare, Inc. / 12896 bottles | Class II | Terminated |
| D-0443-2017 | 12-20-2016 | Temozolomide Capsules, 180 mg, packaged in a) 5-count bottles (NDC 0378-5264-98), b) 14-count bottles (NDC 0378-5264-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA. | Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle. | Mylan LLC. / a) 300 bottles (lot 2006915); b) 156 bottles (lot 2006914) | Class II | Terminated |
| D-0446-2017 | 12-20-2016 | buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-0738-86 | Failed Dissolution Specifications; 18 month stability time point | Sun Pharmaceutical Industries, Inc. / 11,618 bottles | Class III | Terminated |
| D-0442-2017 | 12-20-2016 | Temozolomide Capsules, 140 mg, packaged in a) 5-count bottles (NDC 0378-5263-98), b) 14-count bottles (NDC 0378-5263-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA. | Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle. | Mylan LLC. / a) 746 bottles (lot 2006903); b)588 bottles (lot 2006902) | Class II | Terminated |
| D-0441-2017 | 12-20-2016 | Temozolomide Capsules, 100 mg, packaged in a) 5-count bottles (NDC 0378-5262-98), b) 14-count bottles (NDC 0378-5262-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA. | Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle. | Mylan LLC. / a) 574 bottles (lot 2006895) and 495 bottles (lot 2006896); b) 744 bottles (lot 2006895) | Class II | Terminated |
| D-0444-2017 | 12-20-2016 | Temozolomide Capsules, 250 mg, 5-count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA, NDC 0378-5265-98. | Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle. | Mylan LLC. / 588 bottles | Class II | Terminated |
| D-0445-2017 | 12-20-2016 | buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-737-86), b) 100 (NDC 47335-737-88) and c) 500 (NDC 47335-737-13) count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India Package NDCs: 47335-736-86; 47335-736-88; 47335-736-08; 47335-736-13; 47335-737-86; 47335-737-88; 47335-737-08; 47335-737-13; 47335-738-86; 47335-738-88; 47335-738-08; 47335-738-13 | Failed Dissolution Specifications; 18 month stability time point | Sun Pharmaceutical Industries, Inc. / a) 141,068 bottles b) 56,834 bottles c) 61,692 bottles | Class III | Terminated |
| D-0471-2017 | 12-19-2016 | Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9; Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-3075-3. | Superpotent Drug: Product may not meet specifications throughout shelf life. | Apotex Inc. / 67,946 bottles | Class III | Terminated |
| D-0470-2017 | 12-16-2016 | Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in India for: Auromedics Pharma LLC 6 Wheeling Road, Dayton, NJ 08810, NDC 55150-202-00 Package NDCs: 55150-202-00; 55150-202-10; 55150-202-25 | Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance. | Aurobindo Pharma USA Inc / 29800 vials | Class III | Terminated |
| D-0456-2017 | 12-16-2016 | MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC 63323-412-05 Package NDCs: 63323-411-22; 63323-411-27; 63323-411-15; 63323-411-12; 63323-411-18; 63323-411-25; 63323-411-13; 63323-411-10; 63323-412-18; 63323-412-25; 63323-412-03; 63323-412-02; 63323-412-06; 63323-412-05; 63323-412-13; 63323-412-10 | Failed Impurities/Degradation Specifications | Fresenius Kabi USA, LLC / 47, 020 vials | Class II | Terminated |
| D-0226-2017 | 12-15-2016 | AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For Intravenous Administration Only, Rx Only, Manufactured for: Onyx Pharmaceuticals, Inc., Thousand Oaks, CA 91320-1799, U.S.A., NDC 76075-102-01 Package NDCs: 76075-101-01; 76075-101-21; 76075-102-01; 76075-102-21; 76075-103-01; 76075-103-21 | Lack of Assurance of Sterility: Potential cracks in glass vials | Amgen, Inc. / 11,434 vials | Class II | Terminated |
| D-0227-2017 | 12-15-2016 | Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution, 5 mL bottles, Meta Pharmacy Services. NDC 99999-0106-99 Sterile compounded drug, Hospital/office use only, Not for resale Storage: ROOM TEMP | Lack of Sterility Assurance | Meta Pharmacy Services / 150 mL | Class II | Terminated |
| D-0243-2017 | 12-15-2016 | Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2701 Bristol, PA 19007, NDC 61554-111-04 | CGMP Deviations | Gentell, Inc / unknown | Class II | Terminated |
| D-0242-2017 | 12-15-2016 | Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC 61554-118-28), Manufactured by: Gentell, 2701 Bartram Road, Bristol, PA 19007 | CGMP Deviations | Gentell, Inc / 3,000 gauzes | Class II | Terminated |
| D-0244-2017 | 12-14-2016 | Torsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0234-01 | CGMP Deviations | Apotex Corp. / 35,819 bottles (358,190,000 tablets) | Class II | Terminated |
| D-0245-2017 | 12-14-2016 | Torsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0232-01 | CGMP Deviations | Apotex Corp. / 13,179 bottles (1,317,900 tablets) | Class II | Terminated |
| D-0448-2017 | 12-14-2016 | Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-0293-99 | Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point.. | Roxane Laboratories, Inc. / 74,108 bottles | Class III | Terminated |
| D-0505-2017 | 12-13-2016 | Nano PNC Water, packaged in amber glass bottles, Rx only, ICRPstudy.com, Immune Cellular Restoration Program. | Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled and found to contain variovorax paradoxus. | Pacific Medical Solutions / N/A | Class I | Terminated |
| D-0435-2017 | 12-13-2016 | Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC 0781-5275-31) and b) 1000-count bottles (NDC 0781-5275-10), Rx only, Manufactured in India by Sandoz Private Ltd for Sandoz Inc., Princeton, NJ 08540. | Subpotent Drug: out of specification results for assay test. | Sandoz Inc / a) 10,200 bottles; b) 300 bottles | Class III | Terminated |
| D-0693-2017 | 12-12-2016 | Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC 65162-0724-09), Rx Only, Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad INDIA 382220, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ 08807 | Failed Dissolution Specifications | Amneal Pharmaceuticals LLC / 105,215 Bottles | Class II | Terminated |
| D-0239-2017 | 12-12-2016 | Extra-Virt Plus DHA Prenatal/Postnatal Softgel, Prescription Multivitamin/Mineral Dietary Supplement with Fish-Based DHA , packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-251-30 | cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. | VIRTUS PHARMACEUTICALS OPCO II L / 2,406 bottles | Class III | Terminated |
| D-0241-2017 | 12-12-2016 | VirtPrex Prenatal/Postnatal Tablets, Prescription Supplement Containing Folic Acid and DHA, packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-348-30 | cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. | VIRTUS PHARMACEUTICALS OPCO II L / 124,250 bottles | Class III | Terminated |
| D-0238-2017 | 12-12-2016 | Virt-Advance Prenatal/Postnatal Softgels, Prescription Folic Acid Containing Dietary Supplement, packaged in 90-count bottle, Rx only, Made in Canada, NDC 76439-357-90 | cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. | VIRTUS PHARMACEUTICALS OPCO II L / 2,537 bottles | Class III | Terminated |
| D-0240-2017 | 12-12-2016 | Virt-Select Prenatal/Postnatal Softgels, Prescription Multivitamin/Mineral Dietary Supplement with Fish-Based DHA , packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-249-30 | cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. | VIRTUS PHARMACEUTICALS OPCO II L / 9,795 bottles | Class III | Terminated |
| D-0473-2017 | 12-09-2016 | SLIMFIT X capsules, packaged in a 60-cont bottle | Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and desmethylsibutramine. | Jersey Shore Supplements, LLC / 150 bottles | Class I | Terminated |
| D-0433-2017 | 12-07-2016 | Novacort Gel Sample Packets (2% hydrocortisone acetate, 1% pramoxine HCl), 10-count Carton of 1.0 g sample packets), NDC 69646-704-38 (10 ct. Carton of 1gm samples) / NDC 69646-704-01 (Individual 1gm Samples within Carton), Rx Only, Novum Pharma LLC, Chicago, IL 60654 | Subpotent Drug: Out of specification result for pramoxine hydrochloride | Novum Pharma, LLC / 6,763 1 gram sample packets | Class III | Terminated |
| D-0237-2017 | 12-06-2016 | INOVA (benzoyl peroxide) 4%, Easy Pad (tocopherol) 5%, For topical use only, packaged in a box containing: 30 pads of benzolyl peroxide 3g, 28 capsules of topical tocopherol 5%, OTC, Manufactured for: Innocutis Holdings, LLC, Charleston, SC 29401, NDC 68712-013-01 | Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications. | Cipher Pharmaceuticals US LLC / 216 boxes | Class III | Ongoing |
| D-0425-2017 | 12-06-2016 | 10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx only, Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA, NDC 0338-1130-06 Package NDCs: 0338-1130-03; 0338-1130-04; 0338-1130-06; 0338-1131-03 | Discoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result of oxidation of the amino acid tryptophan due to a damaged overpouch. | Baxter Healthcare Corporation / 3,528 eaches | Class II | Terminated |
| D-0206-2017 | 12-06-2016 | Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48. Package NDCs: 0338-6046-48; 0338-6045-37 | Lack of Assurance of Sterility: confirmed customer complaints of leaking bags. | Baxter Healthcare Corporation / 30,910 bags | Class II | Terminated |
| D-0432-2017 | 12-02-2016 | Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC 54092-189-81 Package NDCs: 54092-189-81; 54092-191-12 | Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules | Shire PLC / 4,520 bottles | Class III | Terminated |
| D-0454-2017 | 12-02-2016 | Endure 400 Scrub-Stat (chlorhexidine gluconate) Foam Forming Solution, 4%, packaged in plastic (HDPE) bottles, Over-the-counter, Model Number: 61430436 (800 mL, 12 bottles/case) - United States; Model Number: 6000179 (800 mL, 12 bottles/case) - Canada, Ecolab, St. Paul, MN 55102, NDC 47593-265-36 | Subpotent Drug | Ecolab, Inc. / 427 bottles | Class III | Terminated |
| D-0431-2017 | 12-01-2016 | Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. | Failed Dissolution Specifications | Teva Pharmaceuticals USA / 6,800 cartons | Class III | Terminated |
| D-0472-2017 | 11-30-2016 | MegaJex Herbal Supplement, Maximum Formula for Men, Fast acting, Increase Stamina, 20 capsules, MS Bionics, Gardena, CA | Marketed without an Approved NDA/ANDA; product contains sildenafil and tadalafil which are active pharmaceutical ingredients in FDA approved drugs used to treat erectile dysfunction (ED) | MS Bionic / 100 bottles | Class I | Terminated |
| D-0494-2017 | 11-23-2016 | Domperidone capsules 10 mg, compounded, dispensed in 60, 90, and 360 count bottles, Jeffreys Drug Store 1 North Central Ave. Canonsburg, PA | Marketed without an approved NDA/ANDA for which safety and efficacy has not been established. | Jeffreys Drug Store / 9 - 30 day scripts | Class I | Terminated |
| D-0225-2017 | 11-22-2016 | Toms of Maine Naturally Dry Natural Powder Antiperspirant Stick, Distributed by: Tom's of Maine, Kennebunk, ME 04043, Made in Canada, Unit UPC: 077326831953 Case UPC: 10077326831950 | Labeling: Label Mix Up- Incorrect back label applied to the product. | Les Emballages Knowlton Inc. / 1,964 cases (35,352 cannisters) | Class III | Terminated |
| D-0516-2017 | 11-22-2016 | PROTONIX I.V. (pantoprazole sodium) for Injection, Equivalent to 40 mg pantoprazole per vial, For I.V. infusion only, Rx Only, Distributed by Wyeth Pharmaceuticals Inc, A subsidiary of Pfizer Inc, Philadelphia, PA 19101, Under license from Takeda GmbH, D78467 Konstanz, Germany, MADE IN FRANCE; packaged in A) Pfizer Injectables, 1 vial per carton (NDC 0008-0923-51) in a) bundles of 10 unit cartons (NDC 0008-0923-55) and b) 25 x 40 mg Vials per carton (NDC 0008-0923-60); B) NOVAPLUS, 1 vial per carton (NDC 00008-0941-01) in 25 x 40 mg Vials per carton (NDC 0008-0941-03); and C) PREMIERPro Rx, 1 vial per carton (NDC 0008-4001-01) in a) bundles of 10 unit cartons (NDC 0008-4001-10) and b) 25 x 40 mg Vials per carton (NDC 0008-4001-25). Package NDCs: 0008-0923-51; 0008-0923-60; 0008-0923-55; 0008-4001-01; 0008-4001-10; 0008-4001-25; 00008-0941-01; 0008-0941-03 | Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point. | Pfizer Inc. / 582,165 vials | Class III | Terminated |
| D-0234-2017 | 11-18-2016 | CVS pharmacy Kids' Ear Relief Oral Liquid 0.85 oz (25 mL) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket RI 02895 NDC 59779-687-02 UPC 77815909639 | CGMP Deviations | Raritan Pharmaceuticals, Inc. / 20,448 bottles | Class II | Terminated |
| D-0232-2017 | 11-18-2016 | CVS Health Homeopathic Infants Teething Tablets 135 count bottle Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 NDC 59779-860-03 UPC 0504284162 | CGMP Deviations | Raritan Pharmaceuticals, Inc. / 45,648 bottles | Class II | Terminated |
| D-0233-2017 | 11-18-2016 | Kids' Relief Ear Relief Oral Liquid 0.85 fl oz. (25 mL) 3025 de'l Assomption Blvd. Montreal, QC H1N 2H2 Canada NDC 60512-913-8 UPC 77815909639 | CGMP Deviations | Raritan Pharmaceuticals, Inc. / 22,704 bottles | Class II | Terminated |
| D-0198-2017 | 11-18-2016 | Midazolam HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL), Single-Dose Syringe, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-001-04 | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Cantrell Drug Company / 37 syringes | Class II | Terminated |
| D-0184-2017 | 11-18-2016 | Calcium Chloride 1 g/50 mL* Added to 5% Dextrose (20 mg/mL)*, Single-Dose Bag, Rx Only, Hospital/Office Use Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-175-37 | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Cantrell Drug Company / 80 bags | Class II | Terminated |
| D-0202-2017 | 11-18-2016 | Rocuronium Bromide 50 mg/5 mL Injection Solution, 5 mL (10 mg/mL) Single-Dose Syringe, Injection Solution For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-064-15 | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Cantrell Drug Company / 5067 syringes | Class II | Terminated |
| D-0191-2017 | 11-18-2016 | Glycopyrrolate 1 mg/5 mL (0.2 mg/mL) Injection Solution, 5 mL Single-Dose Syringe, For IV Use, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-028-15 | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Cantrell Drug Company / 48,592 syringes | Class II | Terminated |
| D-0204-2017 | 11-18-2016 | Succinylcholine Chloride 200 mg/10 mL Injection Solution 10 mL (20 mg/mL) ,Single-Dose Syringe Injection Solution, For Slow IV Use Only ,Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207, NDC 52533-067-12 | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Cantrell Drug Company / 9859 syringes | Class II | Terminated |
| D-0189-2017 | 11-18-2016 | Fentanyl Citrate 2,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 250 mL* Bag, Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Road, AR 72207, NDC 52533-024-61 | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Cantrell Drug Company / 2545 bags | Class II | Terminated |
| D-0188-2017 | 11-18-2016 | Fentanyl Citrate 1,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 150 mL Bag, Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Road, AR 72207, NDC 52533-024-35 | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Cantrell Drug Company / 471 bags | Class II | Terminated |
| D-0195-2017 | 11-18-2016 | HYDROmorphone HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-006-04 | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Cantrell Drug Company / 935 syringes | Class II | Terminated |
| D-0190-2017 | 11-18-2016 | Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride, 100 mL* Bag, Epidural Use Only, Single-Dose Bag, Hospital/Office Use Only, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Road, AR 72207, NDC 52533-080-75 | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Cantrell Drug Company / 2889 bags | Class II | Terminated |
| D-0201-2017 | 11-18-2016 | Oxytocin 30 USP Units Added to 0.9% Sodium Chloride, 500 mL Bag, Single-Dose Bag, Injection Solution for IV Use Only, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-056-30 | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Cantrell Drug Company / 2681 bags | Class II | Terminated |
| D-0203-2017 | 11-18-2016 | Ropivacaine HCl 0.25% in 0.9% Sodium Chloride, 100 mL Bag, Epidural Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-185-75 | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Cantrell Drug Company / 87 bags | Class II | Terminated |
| D-0200-2017 | 11-18-2016 | Neostigmine Methylsulfate 5 mg/5 mL Injection Solution, 5 mL (1 mg/mL) Single-Dose Syringe, For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-046-15 | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Cantrell Drug Company / 24,547 syringes | Class II | Terminated |
| D-0187-2017 | 11-18-2016 | Calcium Chloride, (1 g/10 mL) Injection Solution 10 mL, 10% Single-Dose Vial, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207 | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Cantrell Drug Company / 645 vials | Class II | Terminated |
| D-0193-2017 | 11-18-2016 | Heparin Sodium 5,000 USP Units Added to 0.9% Sodium Chloride 1,000 mL* Bag (5 USP units/mL), Single-Dose Bag.,Hospital/Office Use Only, Injection Solution For IV Use, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-097-24 | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Cantrell Drug Company / 150 bags | Class II | Terminated |
| D-0196-2017 | 11-18-2016 | Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial (1 mg/mL), Single-Dose Injection Solution For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-006-10 | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Cantrell Drug Company / 93 vials | Class II | Terminated |
| D-0197-2017 | 11-18-2016 | Lidocaine HCl 1%, 10 mL Syringe, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207 | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Cantrell Drug Company / 162 syringe | Class II | Terminated |
| D-0186-2017 | 11-18-2016 | Calcium Chloride (20 mg/mL) in 0.9% Sodium Chloride 500 mL Bag, Rx Only, Single-Dose Bag Cantrell Drug Company 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-102-09 | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Cantrell Drug Company / 73 bags | Class II | Terminated |
| D-0199-2017 | 11-18-2016 | Morphine Sulfate 1 mg/mL in 0.9% Sodium Chloride, 100 mL Bag, Single-Dose Bag, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-160-75 | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Cantrell Drug Company / 1748 bags | Class II | Terminated |
| D-0192-2017 | 11-18-2016 | Heparin Sodium, 1 USP Unit/2 mL (0.5 USP Units/mL) in 0.45% Sodium Chloride, Single-Dose Syringe, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-148-16 | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Cantrell Drug Company / 1494 syringes | Class II | Terminated |
| D-0185-2017 | 11-18-2016 | Phenylephrine HCl 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL Single-Dose Syringe, Rx Only Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207, NDC 52533-171-12 | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Cantrell Drug Company / 30,796 syringes | Class II | Terminated |
| D-0194-2017 | 11-18-2016 | HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-002-03 | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Cantrell Drug Company / 2509 syringes | Class II | Terminated |
| D-0289-2017 | 11-17-2016 | Sermorelin Acetate 15 mg. Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 91 vials | Class II | Ongoing |
| D-0261-2017 | 11-17-2016 | HCG 5,000 IU Vial. Compounded by Tri-Coast Pharmacy. | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 4,884 vials | Class II | Ongoing |
| D-0247-2017 | 11-17-2016 | Amino Acid Recover Eaze (50 ML), Phenylaline (L) 8 mg/ml + Tyrosine (L) 0.45 mg/ml + L-Taurine 0.7 mg/ml. Compounded by Tri-Coast Pharmacy. | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 105 vials | Class II | Ongoing |
| D-0282-2017 | 11-17-2016 | Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/3mg/30mg/200mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 10 vials | Class II | Ongoing |
| D-0286-2017 | 11-17-2016 | Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 18mcg/1mg/1.8mg/0.02mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 17 vials | Class II | Ongoing |
| D-0315-2017 | 11-17-2016 | TriMix, Alprostadil/Phentolamine/Papaverine 30mcg/1mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 141 vials | Class II | Ongoing |
| D-0324-2017 | 11-17-2016 | Ultra Slim Shot (Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50 mg/Methylcobalamin 1mg/Carnitine (L) 170mg/Pyridoxine HCL 2mg/Lidocaine HCL 10mg/mL), (30 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 874 vials | Class II | Ongoing |
| D-0290-2017 | 11-17-2016 | Sermorelin Forte 6 mg (Sermorelin Acetate 6 mg/GHRP-6 3 mg). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 7 vials | Class II | Ongoing |
| D-0302-2017 | 11-17-2016 | Testosterone Cypionate in Sesame Oil, 250 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 1,244 vials | Class II | Ongoing |
| D-0285-2017 | 11-17-2016 | Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 40mcg/2mg/40mg/0.04mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 5 vials | Class II | Ongoing |
| D-0271-2017 | 11-17-2016 | Lipotropic with MIC (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25mg/L-Carnitine 170 mg + Methylcopalamin 300 mcg + Thiamine HCL 20 mg + Riboflavin-5-Phosphate Sod 2 mg + Niacinamide 20 mg + Pyridoxine HCL 2 mg + Folic Acid 1 mg/Lidocaine HCL 20mg/ml, (30 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 236 vials | Class II | Ongoing |
| D-0281-2017 | 11-17-2016 | Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/1mg/9mg/0.1mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 2 vials | Class II | Ongoing |
| D-0267-2017 | 11-17-2016 | L-Carnitine 250 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 14 vials | Class II | Ongoing |
| D-0279-2017 | 11-17-2016 | Pyridoxine HCL 100 mg/ml, (30 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 3 vials | Class II | Ongoing |
| D-0274-2017 | 11-17-2016 | Myers Cocktail #4 (Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calcium Gluconate (Anhydrous) 200 mg + Pyridoxine HCL 100 mg + Dexpanthenol 252 mg + Methylcobalamin 2 mg + Thiamine HCL 100 mg + Riboflavin-5-Phosphate Sod 2 mg/10-mL), (10 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 66 vials | Class II | Ongoing |
| D-0323-2017 | 11-17-2016 | Ultra Cocktail #2 (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25 mg/Methylcobalamin 300mcg/Carnitine (L) 170mg/Thiamine HCL 20mg/Riboflavin-5-Phosphate Sod 2mg/Pyridoxine HCL 2mg/Folic Acid 2mg/Ascorbic Acid 20mg/Chromium Picolinate 66mcg/Lidocaine HCL 10mg/mL), (30 ML and 10 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 123 vials | Class II | Ongoing |
| D-0321-2017 | 11-17-2016 | Ultra Amino Blend (Arginine HCL 105 mg + Lysine (L) HCL 150 mg + Ornithine (L) HCL 75 mg + Glutamine (L) 75 mg/ml + Lidocaine HCL 10 mg/mL), (30 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 79 vials | Class II | Ongoing |
| D-0292-2017 | 11-17-2016 | Sermorelin Forte Plus 18 mg (Sermorelin Acetate 6 mg/GHRP-6 6 mg/GHRP-2 6 mg). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 441 vials | Class II | Ongoing |
| D-0308-2017 | 11-17-2016 | Tri-Amino (Ornithine (L) HCL 100 mg/Arginine HCL 100 mg/Citrulline (L) 100 mg/Lidocaine HCL 10 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 78 vials | Class II | Ongoing |
| D-0293-2017 | 11-17-2016 | Sermorelin Forte Plus 27 mg (Sermorelin Acetate 9 mg/GHRP-6 9 mg/GHRP-2 9 mg). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 2116 vials | Class II | Ongoing |
| D-0309-2017 | 11-17-2016 | TriMix, Alprostadil/Phentolamine/Papaverine 40mcg/2mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 17 vials | Class II | Ongoing |
| D-0269-2017 | 11-17-2016 | Lipo-C (Methionine 25 mg/Inositol 50 mg/Choline Chloride 50 mg/Carnitine (L) 100 mg/Methylcobalamin 1 mg/Thiamine HCL 50 mg/Rivoflavin-5-Phosphate Sod 5 mg/Niacinamide 50 mg/Dexpanthenol 5 mg/Pyridoxine HCL 1.25 mg/Lidocaine HCL 10 mg/mL), (30 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 69 vials | Class II | Ongoing |
| D-0272-2017 | 11-17-2016 | Methylcobalamin 1,000 mcg/mL, 10 mL and 30 mL. Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 1,458 vials | Class II | Ongoing |
| D-0251-2017 | 11-17-2016 | BiMix Phentolamine/Papaverine 0.06 mg/1.8 mg/mL (1 ML). Compounded by Tri-Coast Pharmacy. | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 28 vials | Class II | Ongoing |
| D-0283-2017 | 11-17-2016 | Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/1mg/19mg/190mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 10 vials | Class II | Ongoing |
| D-0294-2017 | 11-17-2016 | Sermorelin GT (Sermorelin Acetate 15 mg/GHRP-2 5.4 mg/Theanine (L) 75 mg). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 920 vials | Class II | Ongoing |
| D-0266-2017 | 11-17-2016 | L-Arginine HCL 100 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 41 vials | Class II | Ongoing |
| D-0314-2017 | 11-17-2016 | TriMix, Alprostadil/Phentolamine/Papaverine 20mcg/0.5mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 8 vials | Class II | Ongoing |
| D-0297-2017 | 11-17-2016 | Testosterone Cypionate in Sesame, 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 166 vials | Class II | Ongoing |
| D-0320-2017 | 11-17-2016 | TriMix, Alprostadil/Phentolamine/Papaverine 100mcg/3mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 2 units | Class II | Ongoing |
