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-761-2014 | 06-18-2013 | NeoCitran Extra Strength Non-Drowsy Cold & Sinus (acetaminophen 650 mg and phenylephrine hydrochloride 10 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05703 3. Also packaged under foreign label: Theraflu Daytime Severe Cold powder packets, Natural Lemon flavor, 6-count packets per carton, Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-7116-06, UPC 8 806536 01402 1 (Korea Product) | Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. | Novartis Consumer Health / | Class II | Terminated |
| D-847-2013 | 06-18-2013 | Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5346-01 Package NDCs: 0093-5346-01; 0093-5347-01; 0093-5348-01 | Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing. | Teva Pharmaceuticals USA, Inc. / 16,293 bottles | Class II | Terminated |
| D-752-2014 | 06-18-2013 | Theraflu Multi-Symptom Severe Cold (acetaminophen 500 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Green Tea & Honey Lemon flavors, packaged in a) 6-count packets per carton (NDC 0067-6426-06, UPC 3 0067-6426-06 8) and b) 1-count packet per card (NDC 0067-6426-01, UPC 3 0067-6426-01 3), Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622. Package NDCs: 0067-6426-01; 0067-6426-06 | Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. | Novartis Consumer Health / 1,202,960 cartons and cards | Class II | Terminated |
| D-748-2014 | 06-18-2013 | Theraflu Flu & Sore Throat (acetaminophen 650 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Apple Cinnamon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-7916-06, UPC 3 0043-0479-16 3. Also packaged under foreign label: NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Apple Cinnamon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05205 2. | Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. | Novartis Consumer Health / 1,614,564 cartons | Class II | Terminated |
| D-849-2013 | 06-18-2013 | Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01 Package NDCs: 0093-5346-01; 0093-5347-01; 0093-5348-01 | Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing. | Teva Pharmaceuticals USA, Inc. / 7,579 bottles | Class II | Terminated |
| D-803-2013 | 06-18-2013 | Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73, Rx Only, Manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B2K9, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960. Package NDCs: 0093-2263-01; 0093-2264-01; 0093-4160-76; 0093-4160-78; 0093-4160-73; 0093-4155-79; 0093-4155-73; 0093-4155-80; 0093-4161-76; 0093-4161-78; 0093-4161-73; 0093-2267-01; 0093-2268-01; 0093-3107-01; 0093-3107-05; 0093-3109-53; 0093-3109-05 | Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050. | Teva Pharmaceuticals USA, Inc. / 109,080 Bottles | Class III | Terminated |
| D-848-2013 | 06-18-2013 | Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5347-01 Package NDCs: 0093-5346-01; 0093-5347-01; 0093-5348-01 | Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing. | Teva Pharmaceuticals USA, Inc. / 13,478 bottles | Class II | Terminated |
| D-826-2013 | 06-17-2013 | Belladonna Alkaloids/PB (Belladonna Alkaloids / Phenobarbital) Tablets Phenobarbital USP 16.2 mg, Hyoscyamine Sulfate 0.1037 mg, Atropine Sulfate 0.0194 mg, Scopolamine Hydrobromide 0.0065 mg 30-count bottle (NDC 54868-0031-04), Rx only, Repackaged and distributed by Physicians Total Care, Inc. Tulsa, OK 74146. | Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall. | Physicians Total Care, Inc. / 270 tablets | Class II | Terminated |
| D-919-2013 | 06-17-2013 | ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle, distributed by: Rugby Laboratories, Inc., Duluth, Georgia 30097, NDC 0536-3086-41, UPC 3 0536-3086-41 9. | Labeling: Label Mix-Up: A complaint from a pharmacist was received that the entire contents of 1 bottle labeled as Rugby label Enteric Coated Aspirin 81 mg Tablets actually contained Acetaminophen 500 mg Tablets. | Advance Pharmaceutical Inc / 16,440 bottles | Class I | Terminated |
| D-882-2013 | 06-14-2013 | Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, ten blister cards per carton, Roxanne, Columbus, OH --- NDC 0054-0018-20 Package NDCs: 0054-4741-25; 0054-4741-31; 0054-4742-25; 0054-4728-25; 0054-4728-31; 0054-0017-25; 0054-0017-29; 0054-0017-20; 0054-0018-25; 0054-0018-29; 0054-0018-20; 0054-0019-20; 0054-0019-25; 0054-3722-63; 0054-3722-50; 0054-3721-44; 0054-8739-25; 0054-8740-25; 0054-8724-25 | Labeling: Missing Label; missing label on blister card | Boehringer Ingelheim Roxane Inc / 14,619 cartons | Class III | Terminated |
| D-1442-2014 | 06-13-2013 | ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13. | Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed. | CareFusion 213, LLC / 23,000 Applicators | Class II | Terminated |
| D-807-2013 | 06-13-2013 | Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (labeled as 6,000 kg), Bayer Schering Pharma AG, D-13342 Berlin | Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point. | Bayer HealthCare Pharmaceuticals Inc. / 194.62 kg | Class III | Terminated |
| D-798-2013 | 06-11-2013 | Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP2 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 2 Fine Granular, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60211. | Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. | Church & Dwight Inc / 749 tons total | Class II | Terminated |
| D-799-2013 | 06-11-2013 | Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP3 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 3 Fine Powdered, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60311. | Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. | Church & Dwight Inc / 749 tons total | Class II | Terminated |
| D-801-2013 | 06-11-2013 | Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP5 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 5 Coarse Granular, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60511. | Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. | Church & Dwight Inc / 749 tons total | Class II | Terminated |
| D-800-2013 | 06-11-2013 | Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, Sodium Bicarbonate U.S.P. No. 4 Granular, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60411. | Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. | Church & Dwight Inc / 749 tons total | Class II | Terminated |
| D-797-2013 | 06-11-2013 | Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP1 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 1 Powdered, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60111. | Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. | Church & Dwight Inc / 749 tons total | Class II | Terminated |
| D-921-2013 | 06-11-2013 | Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York | Marketed Without An Approved NDA/ANDA: FDA analysis found this product contained undeclared sibutramine and phenolphthalein, two active ingredients that were once marketed in the U.S. but removed due to safety reasons, making this product an unapproved new drug. | Bethel Nutritional Consulting, Inc / 18,678 bottles | Class I | Terminated |
| D-605-2013 | 06-07-2013 | VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to 10 mL, for IV single use only, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195 (USA); Mfd. by MN Pharmaceuticals; Made in Turkey, NDC 25021-657-10. | CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to Failed Impurities/Degradation Specifications as a high out of specification impurity result was detected during routine quality testing of stability samples. | Sagent Pharmaceuticals Inc / 831,950 vials | Class II | Terminated |
| D-846-2013 | 06-06-2013 | Parsel Plus (reference US product: Excedrin Tension Headache) (Acetaminophen 500 mg and Caffeine 65 mg), packaged in 2-count pouches, Distributed by Novartis Consumer Health, Inc., USA and Novartis Consumer Health S.A., Brazil, for Novartis de Venezuela. The foreign packaging do not have NDC number This product was only distributed to Novartis Brazil by the recalling firm | Defective container: products are packaged in pouches which may not have been fully sealed | Novartis Consumer Health / 472,000 pouches | Class II | Terminated |
| D-843-2013 | 06-06-2013 | Excedrin Extra Strength (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-ct tablets in pouches b) boxes of 50/2-ct packages, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 2030 02 Foreign packaging: c) Parsel Forte and d) Cibalenaa (250 mg Acetaminophen, 250 mg Aspirin, 65 mg Caffeine), boxes of 48/4-ct pouches Foreign packaging do not have NDC numbers. | Defective container: products are packaged in pouches which may not have been fully sealed | Novartis Consumer Health / a) 4,178,000 pouches; b) 101,300 boxes and c) & d) 38,235 pouches and boxes (combined) | Class II | Terminated |
| D-844-2013 | 06-06-2013 | Excedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-count tablets packaged in pouches, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 203 702 Foreign packaging: b) Excedrin Migrana (Acetaminophen 250 mg, Aspirin 250 mg and 65 mg Caffeine) 2-ct pouches. The foreign packaging do not have NDC numbers | Defective container: products are packaged in pouches which may not have been fully sealed | Novartis Consumer Health / 10,624,000 pouches | Class II | Terminated |
| D-608-2013 | 06-06-2013 | 0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-02 | Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container. | Hospira Inc. / 676,872 containers | Class II | Terminated |
| D-845-2013 | 06-06-2013 | No Doz, Max Strength (200 mg caffeine) caplets, 2-count caplets per pouch, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 2070 02 | Defective container: products are packaged in pouches which may not have been fully sealed | Novartis Consumer Health / 4,422,000 pouches | Class II | Terminated |
| D-609-2013 | 06-04-2013 | Cleocin Phosphate (clindamycin Injection), USP, a) 600 mg/4mL (150 mg/mL) ADD-Vantage Vial, b) 900 mg/6mL (150 mg/mL) ADD-Vantage Vial, Rx Only, For Intravenous Use Only, Use Only with the ADD-Vantage diluent container, Distributed by Pharmacia & Upjohn Co, Division of Pfizer Inc, NY, NY 10017, NDC a) 0009-3124-03 and b) 0009-3447-03 Package NDCs: 0009-0870-21; 0009-0870-26; 0009-0775-20; 0009-0775-26; 0009-0902-11; 0009-0902-18; 0009-0728-05; 0009-0728-09; 0009-3124-01; 0009-3124-03; 0009-3447-01; 0009-3447-03; 0009-3381-01; 0009-3381-02; 0009-3375-01; 0009-3375-02; 0009-3382-01; 0009-3382-02; 0009-6582-02; 0009-6582-01 | Presence of Particulate Matter: Firm is recalling a small number of vials with very small reflective flakes consistent with delamination of the glass vial. | Pharmacia & Upjohn LLC / 898,900 Vials | Class II | Terminated |
| D-839-2013 | 06-04-2013 | VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx Only, Mfd. for VersaPharm Incorporated Marietta, GA 30065-1509; Mfd. by: West-ward Pharmaceuticals Corp., Eatontown, NJ 07724 NDC 61748-014-06, | Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification result for description testing for a surface defect of ink. | West-Ward Pharmaceutical Corp. / 118 bottles | Class II | Terminated |
| D-599-2013 | 06-03-2013 | Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in 5-count systems per box (NDC 0591-3212-72), Rx only, Manufactured by Watson Laboratories, Inc, Corona, CA, 92880 USA; Distributed by: Watson Pharma, Inc. | Failed Impurities/Degradation Specifications | Actavis / 98,952 boxes | Class III | Terminated |
| D-630-2013 | 05-31-2013 | Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/2.5 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA, NDC 0046-0875-11 | Failed Dissolution Specifications: Pfizer Inc. is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the dissolution specification for conjugated estrogens. | Pfizer Inc. / 432,657 blister cards | Class III | Terminated |
| D-631-2013 | 05-31-2013 | Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/5.0 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA 1910, NDC 0046-0975-11 | Failed Dissolution Specifications: Pfizer Inc. (Pfizer) is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the specification for conjugated estrogens dissolution. | Pfizer Inc. / 135,520 blister cards | Class III | Terminated |
| D-0250-2015 | 05-31-2013 | Calcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 ml vial, Rx only, Abrams Royal Compounding Pharmacy, 8220 Abrams Rd, Dallas, TX 75231. | Non-Sterility: The firm's contract testing laboratory found sterility failures. | Abrams Royal Pharmacy / 1,100 vials | Class I | Terminated |
| D-607-2013 | 05-31-2013 | Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31), and b) 500-count bottles (NDC 0025-2742-51), Rx only, Distributed by G.D. Searle LLC, Division of Pfizer Inc, NY, NY 10017. Package NDCs: 0025-2752-31; 0025-2762-31; 0025-2732-31; 0025-2742-31; 0025-2742-51 | Failed Dissolution Specification | Pfizer Inc / 5,410 botlles | Class III | Terminated |
| D-808-2013 | 05-30-2013 | Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection for Mycardial and Breast Imaging. For Intravenous Use and Reconstitution. a) Five vials kits: NDC# 45567-0555-1, b) Thirty vials kits: NDC# 45567-0555-2, Rx Only, Manufactured by: Pharmalucence, Inc., Billerica, MA 01821 | Presence of Particulate Matter; particulate found in retain samples | Pharmalucence, Inc. / 17,260 vials | Class III | Terminated |
| D-597-2013 | 05-30-2013 | Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, single-use vial, Manufactured in Austria by Sandoz GmbH for Sandoz, Inc. Princeton, NJ 08540, NDC 00781-3451-70 (vial), NDC 00781-3451-96 (box) | Lack of Assurance of Sterility: Sandoz Inc is recalling Cefazolin for Injection, USP 1 gm vials, lot DB2208, due to a customer complaint for broken/cracked vials which was confirmed through review of retained samples. | Sandoz Incorporated / 297,200 vials | Class II | Terminated |
| D-785-2013 | 05-29-2013 | Taurine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-752-2013 | 05-29-2013 | Meloxicam 5 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 2 | Class II | Ongoing |
| D-781-2013 | 05-29-2013 | Sodium Salicylate 40% Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-777-2013 | 05-29-2013 | Progesterone EO 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-715-2013 | 05-29-2013 | Cre-O-Pan Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-787-2013 | 05-29-2013 | Trimix, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 24 | Class II | Ongoing |
| D-755-2013 | 05-29-2013 | Methylcobalamin P 10/ml Creatine 40 mg/ml / Arginine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-724-2013 | 05-29-2013 | Disodium EDTA Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-761-2013 | 05-29-2013 | Miconazole 3% Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-695-2013 | 05-29-2013 | Alprostadil 2000 mcg/ml, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 5 | Class II | Ongoing |
| D-735-2013 | 05-29-2013 | Gentamicin Sulfate 80 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-745-2013 | 05-29-2013 | Ketamine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-740-2013 | 05-29-2013 | HCG 125iu/0.25ml (550iu/ml), 3500iu and 10,000iu, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 3 | Class II | Ongoing |
| D-717-2013 | 05-29-2013 | Detomidine 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 2 | Class II | Ongoing |
| D-766-2013 | 05-29-2013 | PEN-DEX-CHLOR Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-795-2013 | 05-29-2013 | Xylazine 300 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-762-2013 | 05-29-2013 | Naproxen 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-749-2013 | 05-29-2013 | Lisinopril 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-774-2013 | 05-29-2013 | Potassium Phosphate Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-750-2013 | 05-29-2013 | Medetomidine 2 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-778-2013 | 05-29-2013 | Quadmix, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 3 | Class II | Ongoing |
| D-743-2013 | 05-29-2013 | Iodine 20 mg Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-707-2013 | 05-29-2013 | BNP/Dexamethasone Eye Ointment, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-703-2013 | 05-29-2013 | Beta Alanine 100 mg/ml / l-carnosine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-725-2013 | 05-29-2013 | Doxapram 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-704-2013 | 05-29-2013 | Betamethasone Sodium Phosphate 12 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-727-2013 | 05-29-2013 | Estradiol Cypionate 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-780-2013 | 05-29-2013 | Sodium Iodide 20% Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-770-2013 | 05-29-2013 | Phentolamine 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 5 | Class II | Ongoing |
| D-726-2013 | 05-29-2013 | Enrofloxacin 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-759-2013 | 05-29-2013 | Metoclopramide 5 mg/ml Injection,compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-758-2013 | 05-29-2013 | Methylprednisolone Acetate 80 mg/ml Injection, compounded by Olympia, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-793-2013 | 05-29-2013 | Vitamin B-Buildup Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-773-2013 | 05-29-2013 | Polidocanol (0.75%, 1%, 3%, and 10%) Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 6 | Class II | Ongoing |
| D-728-2013 | 05-29-2013 | Estradiol Cypionate 2 mg/ml Test Cyp 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-734-2013 | 05-29-2013 | Gentamicin 80 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-719-2013 | 05-29-2013 | Dexamethasone Sodium Phosphate 6 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-708-2013 | 05-29-2013 | Buprenorphine 0.3 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 3 | Class II | Ongoing |
| D-739-2013 | 05-29-2013 | HACC 270.1 Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 2 | Class II | Ongoing |
| D-705-2013 | 05-29-2013 | Betamethasone Phosphate/Acetate 6 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-736-2013 | 05-29-2013 | Glutathione 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-718-2013 | 05-29-2013 | Detomidine w/Xylazine 100 mg/mg Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-729-2013 | 05-29-2013 | Fluphenazine 25 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-692-2013 | 05-29-2013 | Acetyl-D-Glucosamine w/Chondroitin 200 mg/ml, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-791-2013 | 05-29-2013 | Vitamin B12 (3000 mcg/ml & 5000 mcg/ml) Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 2 | Class II | Ongoing |
| D-786-2013 | 05-29-2013 | Testosterone Cypionate (100 mg/ml & 200 mg/ml) Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 2 | Class II | Ongoing |
| D-694-2013 | 05-29-2013 | Adenosine-Mono-Phosphate Injection, 200 mg/ml, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-771-2013 | 05-29-2013 | Phenylbutazone 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-741-2013 | 05-29-2013 | Hippiron 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 2 | Class II | Ongoing |
| D-788-2013 | 05-29-2013 | Tripelennamine 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 2 | Class II | Ongoing |
| D-700-2013 | 05-29-2013 | Aminophylline 2.5% Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-760-2013 | 05-29-2013 | MICC (Methionine, Inositol, Choline, Cyanocobalamin, Chromium) Inj and MICC 25/50/330 Inj, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 3 | Class II | Ongoing |
| D-701-2013 | 05-29-2013 | Atipamezole 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 3 | Class II | Ongoing |
| D-746-2013 | 05-29-2013 | Ketoprofen Solution 10% Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-714-2013 | 05-29-2013 | Clenbuterol 0.03mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-713-2013 | 05-29-2013 | Chlorpromazine HCL 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 2 | Class II | Ongoing |
| D-697-2013 | 05-29-2013 | Amikacin Sulfate 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 2 | Class II | Ongoing |
| D-712-2013 | 05-29-2013 | Ceftiofur GM vial 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-756-2013 | 05-29-2013 | Methylcobalamin 1 mg/ml / Folic Acid 2.5 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-723-2013 | 05-29-2013 | Diphenhydramine 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-764-2013 | 05-29-2013 | Oxytocin 20 units/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 3 | Class II | Ongoing |
| D-731-2013 | 05-29-2013 | Gaba 50 mg/Mag Sulfate 50 mg/Taurine/Theanine 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-744-2013 | 05-29-2013 | ITPP 50 mg/ml DMG 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 2 | Class II | Ongoing |
| D-711-2013 | 05-29-2013 | Cal-Phos 1000 Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-792-2013 | 05-29-2013 | Vitamin B12 Cyanocobalamin 5000 mcg Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-748-2013 | 05-29-2013 | Lipotoxin Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 1 | Class II | Ongoing |
| D-782-2013 | 05-29-2013 | Sodium Tetradecyl Sulfate (0.125%, 1%, 2.5%, 3%, and 4%) Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy / 10 | Class II | Ongoing |
