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-1345-2014 | 11-19-2013 | P-BOOST Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack and 5, 10, 20, and 40- count bottles, Distributed by P-Boost, Los Angeles, CA 900466 | Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs. | Tendex / unknown | Class I | Terminated |
| D-1248-2014 | 11-18-2013 | RezzRX capsules, Single Blister Pack and 20 count bottle, Distributed By: Fossil Fuel Products, LLC Atlanta, GA 30309 | Marketed Without an Approved NDA/ANDA: Fossil Fuel Products, is recalling RezzRX due to undeclared hydroxylthiohomosildenafil and aminotadalafil. | Fossil Fuel Products, LLC / 50,300 capsules | Class I | Terminated |
| D-1044-2014 | 11-18-2013 | KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-30, UPC 3 0168-0099-30 9. Package NDCs: 0168-0099-15; 0168-0099-30; 0168-0099-60 | Failed Impurities/Degradation Specifications: Out-of-Specification degradant results. | Fougera Pharmaceuticals Inc. / 31,122 tubes | Class III | Terminated |
| D-1047-2014 | 11-18-2013 | eXtenZone capsules, 1 capsule per blister pack, Distributed by: P.M.C. Company, Buena Park, CA 90621, UPC 6 89076 49126 6. | Marketed Without An Approved NDA/ANDA: FDA analysis found eXtenZone which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved b | SS Wholesale Inc. dba Jobbers Wholesale / 2,395 blister packs total for all products | Class I | Terminated |
| D-1046-2014 | 11-18-2013 | MaXtremeZEN capsules, 1 capsule per blister pack, Distributed by: P&A Enterprise, Buena Park, CA 90621, UPC 6 10079 52468 2. | Marketed Without An Approved NDA/ANDA: FDA analysis found MaXtremeZEN which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved | SS Wholesale Inc. dba Jobbers Wholesale / 2,395 blister packs total for all products | Class I | Terminated |
| D-1045-2014 | 11-18-2013 | Rhino 5 capsules(Spanish & English Labeling), 1 capsule per blister pack, Distributed by P&A Enterprise, Buena Park, CA 90621, English UPC 6 10708 10730 9, Spanish UPC 6 10708 10729 3. | Marketed Without An Approved NDA/ANDA: FDA analysis found Rhino 5 which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved by | SS Wholesale Inc. dba Jobbers Wholesale / 2,395 blister packs total for all products | Class I | Terminated |
| D-1158-2014 | 11-18-2013 | Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1000 mLCLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1115-04. Package NDCs: 0338-1142-03; 0338-1144-03; 0338-1113-04; 0338-1145-03; 0338-1115-04; 0338-1147-03; 0338-1123-04; 0338-1125-04; 0338-1148-03; 0338-0202-01; 0338-0202-06; 0338-0206-01; 0338-0206-04; 0338-0210-01; 0338-0210-06; 0338-0214-01; 0338-0214-04; 0338-7020-01; 0338-7020-06; 0338-7022-01; 0338-7022-06; 0338-7024-01; 0338-7024-04; 0338-7026-01; 0338-7026-06; 0338-7028-01; 0338-7028-04; 0338-7030-01; 0338-7030-06; 0338-7032-01; 0338-7032-04; 0338-7034-01; 0338-7034-06; 0338-7036-01; 0338-7036-04 | Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. | Baxter Healthcare Corp. / 14,574 bags | Class I | Terminated |
| D-1160-2014 | 11-18-2013 | Clinimix 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1099-04. Package NDCs: 0338-1133-03; 0338-1089-04; 0338-1134-03; 0338-1091-04; 0338-1137-03; 0338-1099-04; 0338-1138-03; 0338-1101-04; 0338-0198-01; 0338-0198-06; 0338-0188-01; 0338-0188-06; 0338-0194-01; 0338-0194-04; 0338-0180-01; 0338-0180-06; 0338-0184-01; 0338-0184-04; 0338-7001-01; 0338-7001-06; 0338-7003-01; 0338-7003-04; 0338-7005-01; 0338-7005-06; 0338-7007-01; 0338-7007-04; 0338-7009-01; 0338-7009-06; 0338-7011-01; 0338-7011-04; 0338-7013-01; 0338-7013-06; 0338-7015-01; 0338-7015-04 | Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. | Baxter Healthcare Corp. / 7,388 bags | Class I | Terminated |
| D-1159-2014 | 11-18-2013 | Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-1115-04. Package NDCs: 0338-1142-03; 0338-1144-03; 0338-1113-04; 0338-1145-03; 0338-1115-04; 0338-1147-03; 0338-1123-04; 0338-1125-04; 0338-1148-03; 0338-0202-01; 0338-0202-06; 0338-0206-01; 0338-0206-04; 0338-0210-01; 0338-0210-06; 0338-0214-01; 0338-0214-04; 0338-7020-01; 0338-7020-06; 0338-7022-01; 0338-7022-06; 0338-7024-01; 0338-7024-04; 0338-7026-01; 0338-7026-06; 0338-7028-01; 0338-7028-04; 0338-7030-01; 0338-7030-06; 0338-7032-01; 0338-7032-04; 0338-7034-01; 0338-7034-06; 0338-7036-01; 0338-7036-04 | Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. | Baxter Healthcare Corp. / 7,068 bags | Class I | Terminated |
| D-1057-2014 | 11-18-2013 | 50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containers, Baxter Healthcare Corp., Deerfield, IL --- NDC 0338-1049-02 Package NDCs: 0338-1047-02; 0338-1049-02; 0338-1051-02 | Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper. | Baxter Healthcare Corp. / 49,932 glass containers | Class I | Terminated |
| D-384-2014 | 11-16-2013 | Phenylephrine Nasal 1% Spray, 480 mL bottles, For Office Use, Tower Pharmacy, 26732 Crown Valley Pkwy, Suite 101, Mission Viejo, CA 92691 | Microbial Contamination of Non Sterile Products: Tower Pharmacy is recalling the Phenylephrine Nasal Spray 1% because of possible microbial contamination. | Tower Pharmacy and Compounding / 2 Bottles | Class II | Terminated |
| D-1043-2014 | 11-15-2013 | BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3331-19), c) 500 count bottle (NDC 0591-3331-05), Manufactactred By: Watson Laboratories, Inc. Corona, CA 92880 Package NDCs: 0591-3331-30; 0591-3331-19; 0591-3331-05 | Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months. | Actavis Inc / 139,944 bottles | Class III | Terminated |
| D-747-2014 | 11-14-2013 | Fluconazole Oral Suspension, 10 mg/mL, 35 ml bottle, RX only, Mfd by Cipla, Ltd., Goa, India, Dist by Teva Pharmaceuticals USA, Inc., Sellersville, PA. NDC: 0093-5414-95. | Failed Stability Specifications: this product is below specification for preservative content. | Teva Pharmaceuticals USA, Inc. / 234,242 bottles | Class III | Terminated |
| D-1252-2014 | 11-13-2013 | Glycopyrrolate (MDV) 0.2 MG/ML Injectable, 5 mL Vials, Sterile Serum Vials/Sterile Syringes, for use by a licensed professional only, not for resale, MD Custom Rx, 19035 W Capitol Dr Ste 105, Brookfield, WI 53045. | Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis. | Brookfield Prescription Center Inc / 25 Vials | Class I | Terminated |
| D-1065-2014 | 11-13-2013 | Namenda XR (memantine HCl), sample pack, 28 mg, extended release capsules, packaged in 5-count sample packs, Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045 NDC 0456-3428-05. | Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing. | Forest Pharmaceuticals Inc / 111,384 sample packs | Class III | Terminated |
| D-1063-2014 | 11-13-2013 | Namenda XR (memantine HCl), 7 mg extended release capsules, 30-count bottle, Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045, NDC 0456-3407-33 Package NDCs: 0456-3407-33; 0456-3414-33; 0456-3414-90; 0456-3414-11; 0456-3414-63; 0456-3421-33; 0456-3428-33; 0456-3428-90; 0456-3428-11; 0456-3428-63; 0456-3400-29 | Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing. | Forest Pharmaceuticals Inc / 156 bottles | Class III | Terminated |
| D-1064-2014 | 11-13-2013 | Namenda XR (memantine HCl), titration pack (7 mg, 14 mg, 21 mg and 28 mg) extended release capsules, packaged in 28-capsule, 4 week, titration pack,Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045 NDC 0456-3400-29. Package NDCs: 0456-3407-33; 0456-3414-33; 0456-3414-90; 0456-3414-11; 0456-3414-63; 0456-3421-33; 0456-3428-33; 0456-3428-90; 0456-3428-11; 0456-3428-63; 0456-3400-29 | Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing. | Forest Pharmaceuticals Inc / 3,950 packs | Class III | Terminated |
| D-368-2014 | 11-12-2013 | 10%, Travasol (Amino Acid) Injection, 2000 ml, Pharmacy Bulk Package Not for Direct Infusion, Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. NDC: 0338-0644-06. Package NDCs: 0338-0644-03; 0338-0644-04; 0338-0644-06 | Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured | Baxter Healthcare Corp. / 14,622 bags | Class II | Terminated |
| D-1061-2014 | 11-08-2013 | Valacyclovir Hydrochloride Tablets, 1 g, 30 count bottle, Rx only manufactured in Israel by Teva Pharmaceuticals Ind., LTD, Jerusalem, Israel, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA. NDC #0093-7259-56 | Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragments in bottles of Valacyclovir 1 gm Tablets. | Teva Pharmaceuticals USA, Inc. / 7,020 bottles | Class II | Terminated |
| D-016-2014 | 11-08-2013 | PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple Dose Vial;(NDC 63323-763-50); Rx Only; Manufactured for APP Pharmaceuticals, LLC; Schaumburg, IL 60173; Made in India Package NDCs: 63323-763-05; 63323-763-16; 63323-763-50 | Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections. | Fresenius Kabi USA, LLC / 71,129 vials | Class III | Terminated |
| D-1277-2014 | 11-07-2013 | Adipotrim XT, New Powerful Formula, 30 rapid release capsules per bottle, Dietary Supplement, www.adipotrim.com. | Marketed Without an Approved NDA/ANDA: FDA lab results found undeclared API Fluoxetine in this dietary supplement. | Deseo Rebajar / 1,146 bottles | Class I | Terminated |
| D-367-2014 | 11-07-2013 | Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724. Mfd by: Shasun Chemicals and Drugs Limited, Unit II, R. S. Na 32, 33, 743 PIMS Rd, Periyakalepet, Pondicherry. 605014 INDIA. NDC 0143-9749-10. | Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing | West-Ward Pharmaceutical Corp. / 20,534 bottles | Class II | Terminated |
| D-388-2014 | 11-06-2013 | Sumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only, Rx only, 2 Single-Dose Syringe Cartridges for use with sumatriptan Autoinjector Pen, Manufactured by GlaxoSmithKline, Research Triangle Park, NC 27709 for Sandoz Inc., Princeton, NJ 08540, Made in Singapore, NDC 0781-3173-07. | Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield. | GlaxoSmithKline, LLC. / 9,743 cartridges | Class II | Terminated |
| D-366-2014 | 11-06-2013 | Carbon Dioxide, USP, Medical Gas, Rx only, Non Flammable Gas 2, in 50 lbs steel cylinders, Distributed by AIRGAS USA, LLC Radnor, PA | Labeling: Not Elsewhere Classified; Due to an error in the manufacturing procedure, a cylinder in liquid withdrawal service was not marked Syphon Tube indicating liquid withdrawal and shipped as a gas withdrawal cylinder. | Airgas Medical Services / 264 cylinders | Class II | Terminated |
| D-1087-2014 | 11-06-2013 | Clonazepam Tablets, USP 2 mg 100 tablets Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue, Elizabeth, NJ 0737 USA NDC 0228-3005-11 packaged in White/Round HDPE 75 CC with white/round plastic 33 mm CRC closure shipped in corrugated 75 cc carton (24 bottles/carton) | Subpotent Drug: During routine stability testing one tablet was found with tablet weight below specification. | Actavis Elizabeth LLC / 13,608 bottles | Class II | Terminated |
| D-387-2014 | 11-06-2013 | Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL syringe cartridges each containing 6 mg of sumatriptan for subcutaneous injection only, 1 imitrex STATdose Pen, 1 carrying case, Rx only, 6 mg, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in Singapore, NDC 0173-0479-00 Package NDCs: 0173-0739-00; 0173-0739-02; 0173-0479-00; 0173-0478-00 | Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield. | GlaxoSmithKline, LLC. / 10,469 Systems | Class II | Terminated |
| D-341-2014 | 11-06-2013 | Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bottle, Sandoz Inc., Princeton, NJ 08540, NDC a) 0185-0128-01, b) 0185-0128-05 Package NDCs: 0185-0128-05; 0185-0128-01; 0185-0129-05; 0185-0129-01; 0185-0130-05; 0185-0130-01 | Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions. | Sandoz Inc / 11,496 bottles (100 count) and 62 bottles (500 count) | Class III | Terminated |
| D-746-2014 | 11-05-2013 | sertraline HCl tablets, 25 mg, 30 Tablets, Rx only, GREENSTONE BRAND --- Distributed by: Greenstone LLC, Peapack, NJ 07977 -- MADE IN INDIA --- NDC 59762-4960-1 | Labeling: Incorrect or Missing Lot No. and/or Exp Date: Expiration date incorrectly reflects a 36 month shelf life, instead of the 24 month shelf life | Greenstone LLC / 585,096 bottles | Class II | Terminated |
| D-1058-2014 | 11-04-2013 | Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, Rx only, Distributed by Roerig, Division of Pfizer Inc, NY, NY --- NDC 0049-1550-66 | Failed Dissolution Specification; 8 hr stability timepoint | Pfizer Inc. / 14,357 bottles | Class III | Terminated |
| D-1050-2014 | 11-04-2013 | Hydravax High Potency Diuretic Weight Loss Solution, Pharmaceutical Grade, 45 capsules per bottle, Dietary Supplement, Manufactured and Distributed by Metabolic Nutrition, Sunrise, Florida, www.metabolicnutrition.com | Marketed Without an Approved NDA/ANDA; this product is being recalled for containing an undeclared diuretic called Triamterene, an FDA approved prescription only medication used to treat edema, making it an unapproved new drug | IQ Formulations, LLC / | Class I | Terminated |
| D-1059-2014 | 11-04-2013 | Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only, Distributed by: Greenstone Ltd., Peapack, NJ --- NDC 59762-5032-2 | Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval | Greenstone Llc / 22,529 bottles | Class III | Terminated |
| D-1049-2014 | 11-04-2013 | Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, CT 06410, NDC 25682-001-01, UPC 3 25682-001-01 6. Package NDCs: 25682-001-01 | Presence of Particulate Matter: Failed the appearance test for the presence of visible particles. | Alexion Pharmaceuticals, Inc. / 21,661 vials | Class I | Terminated |
| D-005-2014 | 11-01-2013 | Acetaminophen suspension liquid, 160 mg/5 mL, dye-free grape flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) TopCare Infants' Pain & Fever acetaminophen, Distributed by Topco Associates LLC, Elk Grove Village, IL 60007, NDC 36800-766-16, UPC 0 36800 34650 5; b) Meijer Infants' Pain & Fever acetaminophen oral suspension, Dist. By Meijer Distribution, Inc., 2929 Waler Ave. NW, Grand Rapids, MI 49544, NDC 41250-766-16, UPC 7 13733 31403 9; c) Rite Aid infants' fever reducer & pain reliever oral suspension, Distributed By: Rite Aid, 30 hunter Lane, Camp Hill, PA 17011, UPC 0 11822 35341 0; d) Walgreens infants' Dye-Free Pain & Fever acetaminophen suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0766-16, UPC 3 11917 13223 5; e) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-766-16, UPC 0 41260 35830 2 Package NDCs: 36800-766-16; 41250-766-16; 41250-766-10; 30142-766-16; 0363-0766-16 | Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings. | L. Perrigo Co. / 27,504 bottles | Class II | Terminated |
| D-004-2014 | 11-01-2013 | Acetaminophen suspension liquid, 160 mg/5 mL, cherry flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) leader Infants' Pain & Fever acetaminophen suspension, Distributed by Cardinal Health, Dublin, Ohio 43017, NDC 37205-577-16, UPC 0 96295 12095 0; b) Walgreens infants' Pain & Fever acetaminophen oral suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0161-16, UPC 3 11917 13221 1; c) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-161-16, UPC 0 41260 35831 9; d) H-E-B Pain & Fever acetaminophen suspension Infants', Made With Pride & Care For H-E-B, San Antonio, TX 78204, NDC 37808-161-16, UPC 0 41220 88066 9; e) Babies R Us Infants' Pain & Fever acetaminophen suspension, Distributed by Toys R Us, Inc., Wayne, NJ 07470, NDC 51334-161-16, UPC 7 17851 20094 6; f) healthy accents infants' pain & fever acetaminophen suspension liquid, Distributed By: DZA Brands, LLC, Salisbury, NC 28147/Scarborough, ME 04074, NDC 55316-161-16, UPC 7 25439 95814 1; g) Health Mart Pharmacy infants' pain & fever acetaminophen suspension liquid, Distributed by McKesson, One Post Street, San Francisco, CA 94104, NDC 62011-0002-1, UPC 0 52569 13248 7 Package NDCs: 0363-0161-10; 0363-0161-16; 0363-0161-94; 37808-161-16; 37205-577-16; 30142-161-16; 51334-161-16; 55316-161-16; 62011-0002-1 | Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings. | L. Perrigo Co. / 35,136 bottles | Class II | Terminated |
| D-003-2014 | 11-01-2013 | Acetaminophen suspension liquid, 160 mg/5 mL, dye-free cherry flavor, co-packaged with an oral dosing syringe in a carton and sold under the following: a) equaling infants' pain & fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by SUPERVALU Inc., Eden Prairie, MN 55344, NDC 41163-590-16, UPC 0 41163 48657 7; b) Up & Up dye free infants' pain and fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-590-16, UPC 3 70030 62529 1; c) equate Infants' Pain & Fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-590-16, UPC 6 81131 00185 4; d) Meijer Infants' Pain & Fever acetaminophen oral suspension, 2 FL OZ (59 mL) bottle, Dist. By Meijer Distribution, Inc., 2929 Walker Ave. NW, Grand Rapids, MI 49544, NDC 41250-590-16, UPC 7 13733 31376 6; e) Walgreens infants' Dye-Free Pain & Fever acetaminophen oral suspension, 2 FL OZ (59 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0590-16, UPC 3 11917 13222 8; f) Kroger Infants' Pain & Fever suspension liquid, 4 FL OZ (118 mL) bottle, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-590-26, UPC 0 41260 36738 0; g) Kroger Infants' Pain & Fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-590-16, UPC 0 41260 35829 6; h) Publix Infants' painrelief acetaminophen suspension liquid, 2 FL OZ (59 mL), Distributed By Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, NDC 55062-590-16, UPC 0 41415 39573 2; i) CareOne Infants' Dye-Free Pain Relief acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed By Foodhold U.S.A., LLC, Landover, MD 20785, NDC 41520-590-16, UPC 3 41520 31006 5; j) Harmon FaceValues Infants' Pain & Fever acetaminophen suspension Liquid, 2 FL OZ (59 mL), Distributed by Harmon Stores, Inc., 650 Liberty Ave., Union, NJ 07083 USA, UPC 3 70030 51018 4 Package NDCs: 41250-590-16; 41250-590-10; 30142-590-16; 30142-590-26; 41163-590-16; 11673-590-16; 49035-590-16; 0363-0590-16; 55062-590-16; 41520-590-16 | Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings. | L. Perrigo Co. / 143,892 bottles | Class II | Terminated |
| D-006-2014 | 11-01-2013 | Acetaminophen suspension liquid, 160 mg/5 mL, grape flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) equate Infants' Pain & Fever acetaminophen suspension liquid, Distributed by: Wal-Mart Stores, Inc., Bentonville, AZ 72716, NDC 49035-946-16, UPC 0 78742 09060 3; b) leader Infants' Pain & Fever acetaminophen suspension, Distributed by Cardinal Health, Dublin, OH 43017, NDC 37205-576-16, UPC 0 96295 12093 6; c) TopCare Infants' Pain & Fever acetaminophen, Distributed by Topco Associates LLC, Elk Grove Village, IL 60007, NDC 36800-946-16, UPC 0 36800 34645 1; d) Walgreens infants' Pain & Fever acetaminophen oral suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0946-16, UPC 3 11917 13225 9; e) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-946-16, UPC 0 41260 35832 6 Package NDCs: 49035-946-10; 49035-946-16; 36800-946-16; 36800-946-10; 37205-576-16; 0363-0946-16; 30142-946-16 | Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings. | L. Perrigo Co. / 108,828 bottles | Class II | Terminated |
| D-1109-2014 | 11-01-2013 | Estradiol Cypionate 2mg/cc testosterone cypionoate 50mg | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1137-2014 | 11-01-2013 | Testosterone Cypionate 100mg/ml | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1126-2014 | 11-01-2013 | Papaverine 1nj 30mg/ml | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1110-2014 | 11-01-2013 | Ethanol 20% ophthal. | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-736-2014 | 11-01-2013 | PEGASPARGASE ONCASPAR Injection, 3750 International Units Per 5mL vial, Rx ONLY, sigma-tau PHARMACEUTICALS INC, 9841 Washingtonian Blvd, Gaithersburg, MD 20878 NDC 54482-301-01 | Lack of Assurance of Sterility: Sigma-Tau PharmaSource, Inc. is conducting a voluntary recall of five lots of Oncaspar Injection, because of a crack under the crimp seal which caused a leak. | Sigma-Tau Pharmaceuticals, Inc. / 7479 vials | Class II | Terminated |
| D-1125-2014 | 11-01-2013 | Novarel (IM) | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1102-2014 | 11-01-2013 | Bleomycin Sulfate 1unit/ml | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1141-2014 | 11-01-2013 | Vit A (olive oil) 0.1% opth. | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1142-2014 | 11-01-2013 | Vitamin D (Ergocalciferol) 800 u/ml | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1099-2014 | 11-01-2013 | Acetylcysteine 10% ophthalmic | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-737-2014 | 11-01-2013 | Nifedipine, extended-release tablets, 90mg 100 count blister pack, Rx only, Distributed by: GREENSTONE LLC, Pespack, NJ,07977, NDC 59762-6692-8 | Labeling: Incorrect or Missing Lot and/or Exp Date: Greenstone LLC is recalling Nifedipine Extended Release tablets (90mg). The expiration date on the package is 48 months instead of 36 months. | Greenstone Llc / 21600 tablets | Class II | Terminated |
| D-1101-2014 | 11-01-2013 | Bladder Instillation | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1129-2014 | 11-01-2013 | Pyridoxine (p-f) 100mg/ml | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1120-2014 | 11-01-2013 | Hydroxocobalamin inj. | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1112-2014 | 11-01-2013 | 5-Fluorouracil pf in methocel 1% opthal | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1132-2014 | 11-01-2013 | Scopolamine 0.25 opth. | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1131-2014 | 11-01-2013 | Sodium Bicarbonate 8.4% inj. | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1127-2014 | 11-01-2013 | Papaverine 12mg/phent 1mg/Pros 9mcq/ml | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1107-2014 | 11-01-2013 | Dexamethosone/Tobramycin pf 0.1%/0.3% ophthalmic | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1106-2014 | 11-01-2013 | Dexamethasone (pf) 0.05 % opth. | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1135-2014 | 11-01-2013 | Tacrolimus 0.02% opth. (H20-based) | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1117-2014 | 11-01-2013 | Glutathione 6%/ascorbic 1%/DMSO 6.25% | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1138-2014 | 11-01-2013 | Testosterone Cypionate 200mg/ml | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1133-2014 | 11-01-2013 | Tetracaine 0.5% ophth. | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1121-2014 | 11-01-2013 | Hydroxyprogesterone Caproate | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1134-2014 | 11-01-2013 | Tacrolimus (H20-based) 0.03% ophth. | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1118-2014 | 11-01-2013 | Glutathione 1.25%/Ascorbic 1.25%/DMSO 6.25% | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1116-2014 | 11-01-2013 | L-Glutathione inhalation | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1108-2014 | 11-01-2013 | Dexamethasone phosphate 24mg/ml inj. | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1124-2014 | 11-01-2013 | Methylcobalamin | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1119-2014 | 11-01-2013 | Glutathione Inhalation 200mg/5ml | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1115-2014 | 11-01-2013 | Gentamycin 80mg/1000cc 0.9% NS | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1140-2014 | 11-01-2013 | Vancomycin (fortified) 25mg/ml opth | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1123-2014 | 11-01-2013 | Methotrexate Intraocular 400mcg 0.1cc | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1098-2014 | 11-01-2013 | Lidocaine 4% Urethral Gel | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / 104 syringes | Class II | Terminated |
| D-1143-2014 | 11-01-2013 | Voriconazole 1% opthal | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1100-2014 | 11-01-2013 | AMP/M-B12/Pyridox/Methionine Inositol | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1122-2014 | 11-01-2013 | Idoxuridine 0.1% Ophthalmic | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1111-2014 | 11-01-2013 | EDTA 3% ophthalmic | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1139-2014 | 11-01-2013 | Triamcinolone Acetonide 3mg/ml | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1114-2014 | 11-01-2013 | Folic acid (pf) 10mg/cc inj | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1144-2014 | 11-01-2013 | Voriconazole 0.5mg/ml | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1145-2014 | 11-01-2013 | Voriconazole 0.5mg/ml | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1136-2014 | 11-01-2013 | Terbutaline/Ipratropium 0.5mg/2.5ml | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1130-2014 | 11-01-2013 | Renacidin Irrigation | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1113-2014 | 11-01-2013 | 5-Fluorouracil 1% ophthal | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1104-2014 | 11-01-2013 | Cyano B-12 p-f 1000mcg/ml | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1103-2014 | 11-01-2013 | Cyanocobalamin 100mcg/ml injection | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1128-2014 | 11-01-2013 | Prostaglandin all combinations | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1105-2014 | 11-01-2013 | Cyano B-12 (Cmpd) 1000mcg/ml | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1034-2014 | 10-31-2013 | Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by: Fresenius Kabi USA, LLC Packaged under two labels: 1) Mfd for: APP Pharmaceuticals, LLC; Schaumburg, IL 60173, NDC 63323-563-10, and 2) Mfd in USA; for Nexus Pharmaceuticals Inc; Vernon Hills, IL 60061. NDC 14789-500-10. Package NDCs: 63323-563-01; 63323-563-10; 14789-500-10 | Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container. | Fresenius Kabi USA, LLC / 121,456 vials | Class II | Terminated |
| D-389-2014 | 10-28-2013 | Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx only, Hi-Tech Pharmacal Co, Inc. Amityville, NY 11701. NDC 50383-810-16. | Failed Stability Specification; product viscosity and or pH are below specification. | Hi-Tech Pharmacal Co., Inc. / 51.948 bottles | Class III | Terminated |
| D-001-2014 | 10-24-2013 | Copaxone (glatiramer acetate injection), 20 mg/1 mL, 1 mL pre-filled syringe, packaged in 30 single-use PRE-FILLED Syringes and 33 Alcohol Preps (Swabs) per carton, Rx only, Marketed by: Teva Neuroscience, Inc., Kansas City, MO 64131; Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 68546-317-30, UPC 3 68546 31730 4. Package NDCs: 68546-317-00; 68546-317-30; 68546-325-06; 68546-325-12 | Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe. | Teva Pharmaceuticals USA / 6,803 cartons | Class II | Terminated |
| D-383-2014 | 10-22-2013 | Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz Private ltd. for Sandoz Inc., Princeton, NJ NDC 0781-2102-01 Package NDCs: 0781-2102-01; 0781-2103-01; 0781-2104-01 | Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin | Sandoz Incorporated / 12,521 bottles | Class II | Terminated |
| D-1263-2014 | 10-21-2013 | Human Chorionic Gonadotropin, EP (HCG) in 5 mu. 2 mu, and 1 mu packages, For use and distribution in prescription compounding, manufacturing, processing or repacking only in accordance with FDA regulations and applicable law. Potency 5489.6IU/mg. Packed by Medisca, Inc. Irving, TX, 75063, USA NDC 38779-2673-1, NDC 38779-2673-2, and NDC 38779-2673-6. Lot Numbers 101751/A, Exp: 05/16, CAS: 9002-61-3; 101752/A, Exp: 05/16, CAS 9002-61-3; and 101799/A, Exp: 05/16, CAS: 9002-61-3 | Labeling: Label Error on Declared Strength; Firm states that erroneous potency information was found on the label. | Medisca Inc. / 296 units | Class I | Terminated |
| D-423-2014 | 10-19-2013 | Glutathione PF, 60 mg/mL inhalation, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. | Specialty Medicine Compounding Pharmacy / 126 mL | Class II | Terminated |
| D-431-2014 | 10-19-2013 | METHYLCOBALAMIN * 10 mg/mL INJECTABLE, METHYLCOBALAMIN * UD/PF 25 mg/mL INJECTABLE, METHYLCOBALAMIN* 1000 mcg/mL INJECTABLE, METHYLCOBALAMIN* 25 mg/mL INJECTABLE, METHYLCOBALAMIN* 5000 mcg/mL INJECTABLE, METHYLCOBALAMIN* PF 1000 mcg/mL PREF SYRINGE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. | Specialty Medicine Compounding Pharmacy / 726.45 mL | Class II | Terminated |
| D-432-2014 | 10-19-2013 | Multitrace-4 pediatric injection ( zinc sulfate usp granular heptahydrate, cupric sulfate pentahydrate usp, manganese sulfate monohydrate usp, chromium chloride hexahydrate), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. | Specialty Medicine Compounding Pharmacy / 186 mL | Class II | Terminated |
| D-455-2014 | 10-19-2013 | VIGAMOX (moxifloxacin)* IN BSS (0.15 %) 0.75 mg/0.5 mL PREF SYRINGE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. | Specialty Medicine Compounding Pharmacy / 204 doses | Class II | Terminated |
| D-459-2014 | 10-19-2013 | DT- Tranexamic Acid* 2 gm/100 mL Drug Study -IV 100 mL injectable, DT-, DT-Tranexamic Acid* 2 gm/100 mL-Drug Study-Topical 100 mL Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. | Specialty Medicine Compounding Pharmacy / a) Injectable 600 mL; b) Topical 800 mL | Class II | Terminated |
| D-412-2014 | 10-19-2013 | Bevacizumab, (repackaged) in a) 0.11 mL and b) 0.06 mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. | Specialty Medicine Compounding Pharmacy / 2801 doses | Class II | Terminated |
| D-414-2014 | 10-19-2013 | Combo Eye Gel, HF COMBO EYE GEL* (cyclopentolate 2%, tropicamide 1%, diclofenac sodium 0.1%, ciprofloxacin 0.3%, phenylephrine 10%, lidocaine jelly 2%), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. | Specialty Medicine Compounding Pharmacy / 38 doses | Class II | Terminated |
| D-449-2014 | 10-19-2013 | TESTOS CYPIONATE* IN OIL 100 mg/mL INJECTABLE, TESTOS CYPIONATE* IN OIL 200 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. | Specialty Medicine Compounding Pharmacy / 33 mL | Class II | Terminated |
| D-451-2014 | 10-19-2013 | TRANEXAMIC ACID* 2 g/75 mL SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. | Specialty Medicine Compounding Pharmacy / 3000 mL | Class II | Terminated |
