Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1569-2014 | 08-20-2014 | CHIROTHIN Dietary Supplement, 2 Fl Oz (60 ml), OTC. Manufactured for ChiroNeutraceutical, 877-377-7636, Chesterfield, MO 63005. | Marketed without an Approved NDA/ANDA; Product contains unapproved hHCG. | ChiroNutraceutical LLC / 12,948 Bottles | Class III | Terminated |
| D-1558-2014 | 08-19-2014 | Nicotine Polacrilex Lozenge, 2 mg Mint Mini. 27 Ct Tubes, Over the Counter. Perrigo, 502 Eastern Ave, Plant #6, Allegan, MI 49010. Labeled: A) CareOne, 81 and 108 Ct Cartons, Distributed by: Foodhold U.S.A., LLD, Landover, MD 20785, NDC: 41520-734-02, 41520-734-03, B) CVS Pharmacy, 81 Ct Cartons, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC: 59779-734-02, C) equate, 27, 108, and 135 Ct Cartons, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-734-01, 49035-734-03, 49035-734-04, D) Kroger, 81 Ct Cartons, Distributed by: The Kroger Co., Cincinnati, Ohio 45202, NDC: 30142-734-02, E) Rite Aid, 81 and 108 Ct Cartons, Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC: 11822-0734-3, 11822-0734-2, F) TopCare, 81 Ct Cartons, Distributed by Topco Associates LLC., Elk Grove Villiage, IL 60007, NDC: 36800-734-60 G) Walgreens, 81 and 135 Ct Cartons, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC: 0363-0734-02, 0363-0374-04, H) 20 Ct Stretchcard, Target Corporation, Minneapolis, MN 55403. NDC: 11673-734-02. Package NDCs: 41520-734-01; 41520-734-02; 41520-734-03; 59779-734-01; 59779-734-02; 59779-734-52; 59779-734-60; 59779-734-04; 49035-734-01; 49035-734-03; 49035-734-04; 30142-734-02; 11822-0734-3; 11822-0734-2; 36800-734-60; 0363-0734-02; 0363-0374-04; 11673-734-02 | Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges. | Perrigo Holland Inc / 366,936 Tubes | Class III | Terminated |
| D-0246-2015 | 08-19-2014 | Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540, NDC 42571-010-90 | Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification. | Micro Labs Usa, Inc S / 1,008 bottles | Class III | Terminated |
| D-1545-2014 | 08-13-2014 | PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-604-01 Package NDCs: 63323-604-01 | CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection. | Fresenius Kabi USA, LLC / 56,060 vials | Class II | Terminated |
| D-0010-2015 | 08-13-2014 | METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, (present as the hydrochloride), 10 mL cups, Rx only. Manufactured by VistaPharm Inc., Largo, FL 33771. NDC 66689-031-01. | Defective Container: Product leaks when inverted. | VistaPharm, Inc. / 322,650 Cups | Class II | Terminated |
| D-0229-2015 | 08-08-2014 | CUBICIN (daptomycin for injection) 500 mg, For Intravenous Use Only, Rx Only, Single use Vial, Manufactured for: Cubist Pharmaceuticals Inc., Lexington, MA 02421, USA, NDC 67919-011-01 | Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at the bottom of the vial following reconstitution. | Cubist Pharmaceuticals, Inc. / 371,879 Vials | Class I | Terminated |
| D-1610-2014 | 08-07-2014 | Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code L5B5202, NDC 0941-0457-05. Package NDCs: 0941-0411-05; 0941-0411-06; 0941-0411-07; 0941-0411-04; 0941-0411-11; 0941-0413-05; 0941-0413-06; 0941-0413-07; 0941-0413-01; 0941-0413-04; 0941-0415-05; 0941-0415-06; 0941-0415-04; 0941-0415-07; 0941-0415-01; 0941-0409-06; 0941-0409-05; 0941-0409-07; 0941-0409-01; 0941-0457-08; 0941-0457-02; 0941-0457-05; 0941-0457-01; 0941-0459-08; 0941-0459-02; 0941-0459-05; 0941-0459-01; 0941-0426-52; 0941-0426-53; 0941-0427-52; 0941-0427-53; 0941-0429-52; 0941-0429-53; 0941-0424-51; 0941-0424-52; 0941-0424-53; 0941-0430-51; 0941-0430-52; 0941-0430-53; 0941-0433-51; 0941-0433-52; 0941-0433-53; 0941-0484-01; 0941-0487-01; 0941-0490-01 | Presence of Particulate Matter: particulate matter was found during the manufacturing process. | Baxter Healthcare Corp. / 50,530 bags | Class I | Terminated |
| D0031-2015 | 08-07-2014 | MUSTARCREME, Net Contents: 60g (21 oz) Country of Origin Guyana. | Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A.. | New Gpc Inc. / 1320 units | Class II | Terminated |
| D0029-2015 | 08-07-2014 | alcosulph Moisturizing Cream, Net Contents: 60g. Product packaged within a plastic container individually placed in small carton. Country of Origin Guyana. | Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A.. | New Gpc Inc. / 690 units | Class II | Terminated |
| D0032-2015 | 08-07-2014 | Ferrol EXPECTORANT, Net Contents: 100 mL. Product packaged within a plastic bottle individually placed in small blue carton. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana. | Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A.. | New Gpc Inc. / 36 units | Class II | Terminated |
| D0033-2015 | 08-07-2014 | WHITFIELD LOTION, Net Contents: 60 mL. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana. | Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A.. | New Gpc Inc. / 360 units | Class II | Terminated |
| D0030-2015 | 08-07-2014 | alcosulph Astringent Lotion, Net Contents: 1) 60 mL and 2) 120 mL. Product packaged within a glass container individually placed in small carton. Country of Origin Guyana. | Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A.. | New Gpc Inc. / 900 units | Class II | Terminated |
| D0034-2015 | 08-07-2014 | Whitfield's OINTMENT B.P., Net Contents: 15g. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana. | Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A. | New Gpc Inc. / 4320 units | Class II | Terminated |
| D0035-2015 | 08-07-2014 | Rector's Remedy OINTMENT, Net Contents: 15g. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana. | Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing and lack of OTC drug labeling requirements. | New Gpc Inc. / 2,304 units | Class II | Terminated |
| D-1518-2014 | 08-06-2014 | Alcohol-Free Hand Sanitizer, 1. fl. oz. (30 ml) bottles capped with white sprayer, OTC, contains Benzalkonium chloride. Mfg. for HLI, Portland, OR 97222 NDC: 19392-120-03. Labeled A) Anne Arundel County Mental Health Agency, Inc., B) Family Advocacy Program, and C) Henderson Community College Nursing. | Microbial Contamination of Non-Sterile Product | HLI dba Humphreyline Inc / 975 bottles | Class II | Terminated |
| D-0038-2015 | 08-06-2014 | CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, CHERRY FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0842-54, OTC | Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint. | Qualitest Pharmaceuticals / 101208 units | Class II | Terminated |
| D-0039-2015 | 08-06-2014 | CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, GRAPE FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0843-54, OTC | Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint. | Qualitest Pharmaceuticals / 170113 units | Class II | Terminated |
| D-0037-2015 | 08-06-2014 | CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, BUBBLE GUM FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0841-54, OTC | Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint. | Qualitest Pharmaceuticals / 181908 units | Class II | Terminated |
| D-1571-2014 | 08-05-2014 | Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx only For IV Infusion only, individually boxed, Mfd. for: Akorn, Inc., Lake Forest, IL --- NDC 17478-151-42 | Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point | Akorn, Inc. / 5,539 vials | Class III | Terminated |
| D-0007-2015 | 08-05-2014 | ZyGenerics ATENOLOL Tablets, USP 25 mg 1000 count bottle, Rx Only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08634 USA NDC 68382-022-01 Package NDCs: 68382-022-16; 68382-022-01; 68382-022-10; 68382-022-40; 68382-022-24; 68382-023-16; 68382-023-01; 68382-023-10; 68382-023-02; 68382-023-40; 68382-023-24; 68382-024-16; 68382-024-01; 68382-024-10; 68382-024-40 | Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance. | Zydus Pharmaceuticals USA Inc / 5400 bottles | Class II | Terminated |
| D-1542-2014 | 08-04-2014 | ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bag, Rx only, Baxter Healthcare Corporation, Clinitec Nutrition Division, Deerfield, IL 60015 USA, Product Code 2B6186, NDC 0338-0499-06. | Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine and inorganic material (containing iron, silicone and chlorine). | Baxter Healthcare Corp / 6,204 bags | Class II | Terminated |
| D-0001-2015 | 08-01-2014 | CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington, MA 02421, NDC 67919-011-01, UPC 3 67919-011-01 6. | Presence of Particulate Matter: Potential presence of glass particulate matter in the vials. | Cubist Pharmaceuticals, Inc. / 4,966,575 Vials | Class I | Terminated |
| D-1543-2014 | 07-31-2014 | CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial, Rx only, Distributed by Bedford Laboratories, Bedford, OH 44146, Manufactured by Ben Venue Labs, Inc., Bedford, OH 44146, NDC 55390-808-01 | Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity. | Ben Venue Laboratories Inc / 7172 vials | Class II | Terminated |
| D-1515-2014 | 07-30-2014 | Alprazolam Tablets, USP 0.25 mg, UD 100 Tablets (10 x 10), Rx Only, Mfg By: Sandoz, Inc., Princeton, NJ 08540 --- NDC 63739-644-10 | Presence of Foreign Substance; tablets may contain stainless steel metal particulates | Mckesson Packaging Services / 1240 boxes/124,000 tablets | Class II | Terminated |
| D-1516-2014 | 07-30-2014 | Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manufactured by: Patheon Inc., Whitby Operations, Ontario, Canada L1N 5Z5; Distributed by: Novartis Pharmaceuticals Corp., East Hanover, New Jersey 07936; NDC 0078-0436-05, UPC 3 0078-0436-05 2. | Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers. | Novartis Pharmaceuticals Corp. / 50 bottles | Class III | Terminated |
| D-1537-2014 | 07-30-2014 | Depo-Medrol (methylprednisolone acetate injectable suspension USP), 40 mg/ mL, 1 mL Single-Dose Vial, Rx only, Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, New York NY 10017 NDC 0009-3073-03 DEPO-MEDROL methylprednisolone acetate Injectable Suspension USP, 40 mg per mL, 1 mL Single-Dose Vial, Rx ONLY, Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, New York NY 10017, NOVAPLUS is a registered trademark of Novation, LLC NDC 0009-3073-23 Package NDCs: 0009-3073-01; 0009-3073-03; 0009-3475-01; 0009-3475-03; 0009-3073-22; 0009-3073-23; 0009-3475-22; 0009-3475-23 | Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval at 25C/60%RH. The registered specification for pH is 3.0 - 7.0 | Pfizer Inc. / 93,800 vials | Class III | Terminated |
| D-1583-2014 | 07-30-2014 | 0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-0049-03 Package NDCs: 0338-0049-01; 0338-0049-02; 0338-0049-03; 0338-0049-04; 0338-0049-10; 0338-0049-41; 0338-0049-11; 0338-0049-31; 0338-0049-48; 0338-0049-18; 0338-0049-38; 0338-0043-03; 0338-0043-04 | Lack of Assurance of Sterility; complaints of mold in the overpouch | Baxter Healthcare Corp. / 157,080 containers | Class II | Terminated |
| D-0020-2015 | 07-29-2014 | Lidocaine HCl Injection, USP, 2%, 20 mg per mL, Preservative-Free, 5 mL Single-Dose Vial, Rx only, For Infiltration and Nerve Block including Epidural and Caudal, Manufactured by: Hospira, Inc., Lake Forest, IL, 60045, NDC 0409-2066-05 Package NDCs: 0409-2066-10; 0409-2066-05 | Presence of Particulate Matter: The product was discolored and contained visible particulates (iron oxide) in the solution and embedded in the glass vial. | Hospira Inc. / 109,110 Vials | Class I | Terminated |
| D-1486-2014 | 07-28-2014 | OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane Laboratories. Roxane Laboratories, Inc. Columbus, Ohio 43216. NDC: 0054-0523-41. | Failed Stability Specifications: Out of specification result for preservative sodium benzoate. | Boehringer Ingelheim Roxane Inc / 2,149 Bottles | Class III | Terminated |
| D-1509-2014 | 07-25-2014 | Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061-10 Package NDCs: 0781-1061-01; 0781-1061-05; 0781-1061-10; 0781-1077-01; 0781-1077-05; 0781-1077-10; 0781-1079-01; 0781-1079-05; 0781-1079-10; 0781-1089-01; 0781-1089-05 | Presence of Foreign Substance; tablets may contain stainless steel metal particulates | Sandoz Incorporated / 1,332 bottles | Class II | Terminated |
| D-1498-2014 | 07-24-2014 | Fagron, Pentravan Plus Base 2.5 Kg, Article number: 804749. RX only, For prescription compounding, Oil-in-water emulsion base alternative to PLO gel, Added emulsifier ad viscosity-enhancing agent for use with high concentrations of active ingredients.Pre served and fragrance-free, Manufactured by: Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120, NDC 51552-1285-8, | Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold. | Fagron, Inc / 99 jars | Class II | Terminated |
| D-1496-2014 | 07-24-2014 | Fagron, Phytobase Cream, 500 g, Article number: 802156. RX only, For prescription compounding Natural self-emulsifying oil-in water vehicle for oil-solvents ingredients. Contains Phytosomes (Plant Oil Bodies), Manufactured by Fagron, Inc. 2400 Pilot Knob Rd, St Paul, MN 55120, NDC 51552-1205-6. | Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold. | Fagron, Inc / 430 jars | Class II | Terminated |
| D-1497-2014 | 07-24-2014 | Fagron, Pentravan Base 2.5 Kg, Article number: 802486. RX only, For prescription compounding, Oil-in-water emulsion, PLO gel alternative, Preserved and fragrance-free, Manufactured by; Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 NDC 51552-0919-8. | Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold. | Fagron, Inc / 97 jars | Class II | Terminated |
| D-0982-2015 | 07-24-2014 | Epel 18 mg Estradiol Pellet, For In Office Use Only, For In Office Administration Only, Not for Resale or Dispensing to an Individual Patient, Rx Only, Preferred Physician Medical LLC, 405-551-8216 | Non-Sterility: The recalled lot failed sterility testing. | Physician Preferred Medical, LLC / 122 Pellets | Class I | Terminated |
| D-1541-2014 | 07-24-2014 | Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b) 500-count bottle (NDC 64679-737-03) Rx only, Manufactured by: Wockhardt Limited Mumbai, India Distributed by: Wockhardt USA LLC 20 Waterview Boulevard. Parsippany, NJ 07054 USA | Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point. | Wockhardt Usa Inc. / 11,661 HDPE bottles | Class II | Terminated |
| D-0255-2015 | 07-18-2014 | Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle. Spectrum Chemical MFG CORP., Gardena, CA 90248. Cat. YY1568. | CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy. | Spectrum Laboratory Products / 16 Bottles | Class II | Terminated |
| D-0011-2015 | 07-18-2014 | N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133 | Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense. | Unique Pharmaceutical, Ltd / 3,529 Vials | Class I | Terminated |
| D-0012-2015 | 07-18-2014 | All sterile products within expiry | Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products intended to be sterile. | Unique Pharmaceutical, Ltd / 325,225 units (syringes, vials, bags) | Class II | Terminated |
| D-1444-2014 | 07-17-2014 | Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals Inc., Big Flats, NY 14814, NDC 39822-2000-1. Package NDCs: 39822-2000-1; 39822-2010-1 | Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each mL contains 500 mcg Clonidine Hydrochloride" instead of stating "Each mL contains 100 mcg Clonidine Hydrochloride". | X-Gen Pharmaceuticals Inc. / 8,356 vials | Class III | Terminated |
| D-1517-2014 | 07-17-2014 | Tetrahydrozoline HCL, 16 kg drum. Societa Italiana Medicinali Scandicci (S.I.M.S.), Made in Italy. NDC 12660-0048 CAS #522-48-5 | CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy. | SST Corporation / 1 Drum | Class II | Terminated |
| D-0028-2015 | 07-16-2014 | Rugby Children's Pain and Fever Acetaminophen Oral Suspension 160 mg/5 mL, Cherry Flavor, 2 FL. oz bottle, OTC, Distributed by: Rugby Laboratories Livonia, MI 48150, NDC 0536-3606-96 Major Children's Mapap Suspension Liquid, Cherry Flavor, 4 FL OZ bottle, OTC, Distributed by: Major Pharmaceuticals Livonia, MI 48150 , NDC 0904-6308-20, | Superpotent Drug: Bio-Pharm, Inc. is initiating a recall of one lot of Acetaminophen Oral Suspension Liquid 160mg/5mL failure of the product assay at the 6 month timepoint. | Bio-pharm, Inc. / 35,739 bottles | Class II | Terminated |
| D-1608-2014 | 07-15-2014 | Daytrana (methylphenidate transdermal system) patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count patches per box, Rx Only. Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5554-3. Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration. | Noven Pharmaceuticals, Inc. / 160,800 patches | Class II | Terminated |
| D-1513-2014 | 07-14-2014 | buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA, LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, NDC 64679-101-07. | Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed. | Wockhardt Usa Inc. / 840 bottles | Class III | Terminated |
| D-1502-2014 | 07-12-2014 | Benicar Tablets (olmesartan medoxomil) 20 mg, 30 and 90 count, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-103-30 and NDC 65597-103-90 | Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping | Daiichi Sankyo Pharma Development / 262 bottles | Class II | Terminated |
| D-1503-2014 | 07-12-2014 | Benicar HCT Tablets (olmesartan medoxomil, hydrochlorothiazide) 20 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-105-30 | Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping | Daiichi Sankyo Pharma Development / 108 bottles | Class II | Terminated |
| D-1506-2014 | 07-12-2014 | Benicar Tablets (olmesartan medoxomil) 40 mg, 30 and 90 count, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-104-30 and 65597-104-90 | Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping. | Daiichi Sankyo Pharma Development / | Class II | Terminated |
| D-1508-2014 | 07-12-2014 | Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/25 mg, 30 and 90 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-107-30 and NDC 65597-107-90 | Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping. | Daiichi Sankyo Pharma Development / | Class II | Terminated |
| D-1507-2014 | 07-12-2014 | Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-106-30 | Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping. | Daiichi Sankyo Pharma Development / 86 bottles | Class II | Terminated |
| D-1501-2014 | 07-12-2014 | Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg*/40 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc. Parsippany, NJ 07054 NDC 65597-113-30 | Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping | Daiichi Sankyo Pharma Development / 5 bottles | Class II | Terminated |
| D-1505-2014 | 07-12-2014 | Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 ---NDC 65597-701-18 | Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping | Daiichi Sankyo Pharma Development / 68 bottles | Class II | Terminated |
| D-1504-2014 | 07-12-2014 | Tribenzor Tablets (olmesartan medoxomil/amlodipine/hydrochlorothiazide), 40 mg/5 mg*/25 mg 30 count bottles, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-116-30 | Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping | Daiichi Sankyo Pharma Development / | Class II | Terminated |
| D-1593-2014 | 07-11-2014 | Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0703-41, Product Code 2B0822. Package NDCs: 0338-0703-41; 0338-0703-48; 0338-0705-41; 0338-0705-48; 0338-0709-48 | Presence of Particulate Matter: particulate matter identified as fibers and/or plastics | Baxter Healthcare Corp. / 171,672 bags | Class I | Terminated |
| D-1592-2014 | 07-11-2014 | 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0553-18, Product Code 2B0043. Package NDCs: 0338-0553-11; 0338-0553-18 | Presence of Particulate Matter: particulate matter identified as fibers and/or plastics. | Baxter Healthcare Corp. / 390,560 bags | Class I | Terminated |
| D-1500-2014 | 07-11-2014 | Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC # 59746-339-90 Package NDCs: 59746-337-30; 59746-337-90; 59746-337-01; 59746-337-10; 59746-338-30; 59746-338-90; 59746-338-01; 59746-338-10; 59746-339-30; 59746-339-90; 59746-339-01; 59746-339-10 | Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel. | Jubilant Cadista Pharmaceuticals Inc. / 9,358 bottles | Class II | Terminated |
| D-1591-2014 | 07-11-2014 | 0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41, Product Code 2B1306; and b) 100 mL VIAFLEX Container bags, NDC 0338-0049-18, Product Code 2B1302, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Package NDCs: 0338-0049-01; 0338-0049-02; 0338-0049-03; 0338-0049-04; 0338-0049-10; 0338-0049-41; 0338-0049-11; 0338-0049-31; 0338-0049-48; 0338-0049-18; 0338-0049-38; 0338-0043-03; 0338-0043-04 | Presence of Particulate Matter: particulate matter identified as fibers and/or plastics. | Baxter Healthcare Corp. / a) 217,536 bags; b) 161,760 bags | Class I | Terminated |
| D-1445-2014 | 07-11-2014 | Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540. Package NDCs: 0185-0022-10; 0185-0022-01 | Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing. | Sandoz Inc / 781,000 extended release tablets | Class III | Terminated |
| D-0392-2015 | 07-10-2014 | LACTATED RINGER'S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers, Rx Only, Hospira, Inc., Lake Forest, IL 600045, NDC 0409-7929-09 | Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of the primary container, consistent with mold. | Hospira Inc. / 142,644 bags | Class I | Terminated |
| D-0022-2015 | 07-09-2014 | Propranolol HCl, NET WT 1 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0004 | cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices. | Gyma Laboratories Of Amer,Inc / 1 Kg | Class II | Terminated |
| D-0021-2015 | 07-09-2014 | Dipyridamole API, NET WT 10 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0084 | cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices. | Gyma Laboratories Of Amer,Inc / 10 Kg | Class II | Terminated |
| D-0024-2015 | 07-09-2014 | Clonidine HCL, 97 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0002 | cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices. | Gyma Laboratories Of Amer,Inc / 97 Kg | Class II | Terminated |
| D-0023-2015 | 07-09-2014 | Clonidine Base Micronized, 55.8 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 12660-0503-01 | cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices. | Gyma Laboratories Of Amer,Inc / 55.8 Kg | Class II | Terminated |
| D-1443-2014 | 07-08-2014 | VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only, Manufactured by: Agouron Pharmaceuticals, Inc. A Pfizer Company, Distributed by: ViV Healthcare Company, Research Triangle Park, NC 27709 NDC 63010-027-70 Package NDCs: 63010-010-30; 63010-027-70 | Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016. The correct expiry date is 09/2016. | Pfizer Inc. / 1200 tablets | Class III | Terminated |
| D-0009-2015 | 07-03-2014 | Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, Rx only, Mfg by Mylan Pharmaceuticals, Inc. Morgantown, WV 26505. NDC 0378-4596-77. | Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and markings in bottle of Metoprolol | Mylan Pharmaceuticals Inc. / 15,966 bottles | Class II | Terminated |
| D-1441-2014 | 07-03-2014 | Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0336-60. | Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry. | Fougera Pharmaceuticals Inc. / 3,594 Bottles | Class III | Terminated |
| D-1435-2014 | 07-03-2014 | Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08. | Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing. | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) / 1,184 cartons | Class III | Terminated |
| D-1440-2014 | 07-03-2014 | Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0337-60. | Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry. | Fougera Pharmaceuticals Inc. / 111,388 Bottles | Class III | Terminated |
| D-1536-2014 | 07-02-2014 | E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc., Lake Success, NY 11042, NDC 32909-764-01. Package NDCs: 32909-764-01 | Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months. | Bracco Diagnostic Inc / 216,792 bottles | Class III | Terminated |
| D-1590-2014 | 07-01-2014 | Oxcarbazepine Tablets, 300 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, OH 43217, NDC 62584-143-01 | Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544. | American Health Packaging / 59,200 tablets | Class I | Terminated |
| D-1589-2014 | 07-01-2014 | Ibuprofen Tablets, USP, 600 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, OH 43217, NDC 68084-0703-01 | Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544 | American Health Packaging / 137,300 tablets | Class I | Terminated |
| D-1554-2014 | 06-27-2014 | fentaNYL 2750 mcg/55 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG, For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478 NDC 75901-8008-33 | Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing. | Healix Infusion Therapy, Inc. / 220 syringes | Class II | Terminated |
| D-1552-2014 | 06-27-2014 | fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride in flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478, NDC 75901-8002-04 | Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing. | Healix Infusion Therapy, Inc. / 48 bags | Class II | Terminated |
| D-1551-2014 | 06-27-2014 | fentaNYL 1500 mcg/30 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478 NDC 75901-8008-90 | Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing. | Healix Infusion Therapy, Inc. / 50 syringes | Class II | Terminated |
| D-1553-2014 | 06-27-2014 | fentaNYL 200 mcg/100 mL (2 mcg/mL) and Ropivacaine 0.2% in 0.9% Sodium Chloride 100mL, in flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc., at 866-299-4826, 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478, NDC 75901-8007-02 | Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing. | Healix Infusion Therapy, Inc. / 12 bags | Class II | Terminated |
| D-1555-2014 | 06-27-2014 | fentaNYL 5000 mcg/250 mL (20 mcg/mL) in 0.9% Sodium Chloride in a flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale, Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478, NDC 75901-8015-04 | Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing. | Healix Infusion Therapy, Inc. / | Class II | Terminated |
| D-1433-201 | 06-27-2014 | Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only. Hospira, Inc., Lake Forest, IL 60045. NDC: 0409-9094-61. Package NDCs: 0409-9093-41; 0409-9093-36; 0409-9093-31; 0409-9093-38; 0409-9094-12; 0409-9094-22; 0409-9094-18; 0409-9094-25; 0409-9094-17; 0409-9094-28; 0409-9094-16; 0409-9094-31; 0409-9094-41; 0409-9094-61; 0409-9094-44; 0409-9094-55 | Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing. | Hospira Inc. / 47,400 vials | Class II | Terminated |
| D-1510-2014 | 06-26-2014 | Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 62756-293-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India. | CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices. | Caraco Pharmaceutical Laboratories, Ltd. / a) 70,152 bottles; b) 43,525 bottles | Class II | Terminated |
| D-1432-2014 | 06-26-2014 | LORTUSS EX, Each 5 mL (1 teaspoonful) contains: Codeine Phosphate 10 mg, Guaifenesin 100 mg, Psuedoephedrine HCl 22.5 mg, 16 fl oz. (473 mL), Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL 36619. NDC: 50991-515-16. | Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only". | Poly Pharmaceuticals, Inc / 102 Bottles | Class III | Terminated |
| D-1431-2014 | 06-26-2014 | POLY-TUSSIN AC LIQUID, Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate 4 mg, Codeine Phosphate 10 mg, Phenylephrine HCl 7.5 mg, 16 fl oz. (473 mL) Bottle, Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL 36619. NDC: 50991-713-16. | Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only". | Poly Pharmaceuticals, Inc / 208 Bottles | Class III | Terminated |
| D-1511-2014 | 06-26-2014 | Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and b) 500-count bottles (NDC 62756-294-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India. | CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices. | Caraco Pharmaceutical Laboratories, Ltd. / a) 43,585 bottles; b) 296,968 bottles | Class II | Terminated |
| D-1522-2014 | 06-25-2014 | Vitamin B12 Cyanocobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us | Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer | Medical Supply Liquidators Llc / N/A | Class II | Terminated |
| D-1533-2014 | 06-25-2014 | Glutathione Injection USP, 200 mg/ml, packaged in 30 ml vials, Sterile, For IM of Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us. | Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer | Medical Supply Liquidators Llc / N/A | Class II | Terminated |
| D-1519-2014 | 06-25-2014 | Vitamin B12 Methylcobalamin with MIC Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial. For IM or Deep SQ Use, Multiple Dose Vial. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us | Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer | Medical Supply Liquidators Llc / N/A | Class II | Terminated |
| D-1520-1014 | 06-25-2014 | Vitamin B12 Methylcobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial. For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us | Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer | Medical Supply Liquidators Llc / N/A | Class II | Terminated |
| D-1532-2014 | 06-25-2014 | L-Carnitine Injection USP 100 mg/ml, packaged in 30 ml vials, Sterile, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us. | Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer | Medical Supply Liquidators Llc / N/A | Class II | Terminated |
| D-1521-2014 | 06-25-2014 | BCAA 4% Branched Chain Amino Acid Injection USP, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us | Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer | Medical Supply Liquidators Llc / N/A | Class II | Terminated |
| D-1524-2014 | 06-25-2014 | Vitamin B12 Methylcobalamin 5000 Injection USP 5000 mcg/ml, 10 ml vial and 30 ml vial, Sterile, for IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us. | Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer | Medical Supply Liquidators Llc / N/A | Class II | Terminated |
| D-1530-2014 | 06-25-2014 | Lipo 8 Injection USP 200 mg/ml, packaged in 30 ml vials, Sterile, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us. | Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer | Medical Supply Liquidators Llc / N/A | Class II | Terminated |
| D-1529-2014 | 06-25-2014 | Vitamin B12 Hydroxocobalamin Injection USP 1000 mcg/ml, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us. | Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer | Medical Supply Liquidators Llc / N/A | Class II | Terminated |
| D-1525-2014 | 06-25-2014 | MIC Injection USP, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us | Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer | Medical Supply Liquidators Llc / N/A | Class II | Terminated |
| D-1531-2014 | 06-25-2014 | G.A.C. 375 Injection USP, packaged in 30 ml vials, Sterile, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us. | Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer | Medical Supply Liquidators Llc / N/A | Class II | Terminated |
| D-1526-2014 | 06-25-2014 | Super MIC B Complex for L-Carnitine for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM or Deep SQ Use, Multiple Dose Vial. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us. | Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer | Medical Supply Liquidators Llc / N/A | Class II | Terminated |
| D-1528-2014 | 06-25-2014 | B Complex for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM or Deep SQ use, multiple dose vial, packaged in 10 ml vials and 30 ml vials. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us. | Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer | Medical Supply Liquidators Llc / N/A | Class II | Terminated |
| D-1523-2014 | 06-25-2014 | Vitamin B6 Pyridoxine HCL for Injection USP, 100 mg/ml, Sterile, for IM or Deep SQ Use, Multiple Dose 30 ml vial, manufactured by: CB Inc. for Sunshine Labs, www. sunshinelabs.us. | Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer | Medical Supply Liquidators Llc / N/A | Class II | Terminated |
| D-1546-2014 | 06-25-2014 | Ascorbic Acid 500 mg/mL Sterile Injection, 50 mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869. | Non-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold contamination. | Pharmacy Creations / 70 vials | Class I | Terminated |
| D-1527-2014 | 06-25-2014 | Vitamin B12 Cyanocobalamin with MIC Injection USP 1000 mcg/ml, packaged in 10 ml vials and 30 ml vials, Sterile, for IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us. | Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer | Medical Supply Liquidators Llc / N/A | Class II | Terminated |
| D-1549-2014 | 06-24-2014 | Doctor's Best Red Yeast Rice 1200, 600 mg Capsules, 120-count bottle. UPC 753950001183, Manufactured for Doctor's Best San Clemente, CA 92673 | Marketed Without an Approved NDA/ANDA: FDA analysis discovered undeclared lovastatin, making this an unapproved new drug. | Doctor's Best, Inc. / 7,379 bottles | Class II | Terminated |
| D-1539-2014 | 06-20-2014 | Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-5445-91. | Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities. | Mylan Pharmaceuticals Inc. / 9225 Bottles | Class III | Terminated |
| D-1484-2014 | 06-20-2014 | Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873. Distributed by: Gavis Pharmaceuticals, LLC, Somerset, NJ 08873, NDC 43386-500-11. Package NDCs: 43386-500-11 | Failed Impurity/Degradation Specification; 12-month stability time point | Novel Laboratories, Inc. / 25,776 containers | Class III | Terminated |
| D-1557-2014 | 06-19-2014 | Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05. | Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing. | Mylan Pharmaceuticals Inc. / 2,658 Bottles | Class III | Terminated |
| D-1412-2014 | 06-19-2014 | Bystolic (nebivolol) tablets, 20 mg/tablet. 7 Tablet Professional Sample Bottle, Rx Only. Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, Missouri 63045. NDC 0456-1420-07. | Failed Dissolution Specifications: Drug failed stage III dissolution testing. | Forest Pharmaceuticals Inc / 92,544 Bottles | Class II | Terminated |
