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-0135-2018 | 11-10-2017 | Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spain, Distributed by: Bayer Healthcare LLC Morristown, NJ 07962 NDC 0280-2160-36 UPC 3128431310577 | Failed Stability Specifications | Bayer HealthCare Pharmaceuticals, Inc. / 104,128 HDPE bottles | Class III | Terminated |
| D-0573-2018 | 11-10-2017 | Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10 Package NDCs: 43066-150-10; 43066-360-20 | Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged | Baxter Healthcare Corporation / 35,628 single-dose containers | Class I | Terminated |
| D-0551-2018 | 11-09-2017 | GERICARE Eyewash, sterile eye irrigating solution, packaged in a 4 fl oz (118 mL) bottle, OTC, Distributed by Geri-Care Pharmaceuticals Corp., Brooklyn, NY 11204, NDC 57896-0186-04 | Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans | Kareway Products Inc / 60,000 bottles | Class I | Terminated |
| D-0096-2018 | 11-09-2017 | Clozapine Tablets USP, 100 mg, 500 count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICALS IND, LTD, Jerusalem Israel, Manufactured For: TEVA PHARMACEUTICALS USA, North Wales, PA, NDC 00093-7772-05 | Failed Tablet/Capsule Specifications; potential presence of broken tablets. | Teva Pharmaceuticals USA / 3,870 bottles | Class II | Terminated |
| D-0098-2018 | 11-09-2017 | Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distributed by Perrigo Minneapolis, MN 55427, NDC 0574-0222-01 | Failed Dissolution Specifications. | Mayne Pharma Inc / 11,364 bottles | Class II | Terminated |
| D-0128-2018 | 11-08-2017 | Maximum Strength Zephrex-D, Pseudoephedrine HCl, 30 mg, Nasal Decongestant. 24 softgel tablets per paper carton, Distributed by Perrigo, Allegan, MI 49010, NDC 70085-151-01 | Microbial Contamination of Non-Sterile Products | L. Perrigo Company / 19,944 Cartons (24 tablets each) | Class II | Terminated |
| D-0093-2018 | 11-06-2017 | Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01), packaged in 25 x 1 mL Vials per shelf pack (NDC 0641-6145-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ 07724 USA. Package NDCs: 0641-0367-21; 0641-0367-25; 0641-6145-01; 0641-6145-25; 0641-6146-01; 0641-6146-10; 0641-6146-25 | Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound). | West-Ward Pharmaceuticals Corp. / 16,157 shelf packs | Class III | Terminated |
| D-0094-2018 | 11-06-2017 | Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials (NDC 0641-6146-01), packaged in 25 x 5 mL Vials per shelf pack (NDC 0641-6146-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ 07724 USA. Package NDCs: 0641-0367-21; 0641-0367-25; 0641-6145-01; 0641-6145-25; 0641-6146-01; 0641-6146-10; 0641-6146-25 | Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound). | West-Ward Pharmaceuticals Corp. / 1,896 shelf packs | Class III | Terminated |
| D-0127-2018 | 11-06-2017 | Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, Rx Only, (2 mg/mL), 100 mL Flexible Bag, Manufactured for: Claris LifeScience Inc. North Brunswick NJ 08902 by Claris Injectables Ltd. Gujarat, India UPC 336000008242 NDC 36000-008-249 | Superpotent | Claris Lifesciences Inc / | Class III | Terminated |
| D-0090-2018 | 11-03-2017 | Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine, (lidocaine HCL 4%), 1/2 oz Balm (NDC 69804-014-06), and 2 oz Balm(NDC 69804-014-03), Manufactured by Pain Relief Naturally, www.Naturally HL.com | GMP Deviations: inadequate manufacturing control processes | Ridge Properties, LLC / N/A | Class II | Terminated |
| D-0089-2018 | 11-03-2017 | Extra Strength Naturally HL Liquid Hemorrhoid Relief Gel, (lidocaine HCL 4%), 1/2 oz Liquid Gel (NDC 69804-024-13), 1 oz Liquid Gel (NDC 69804-024-14), 2 oz Liquid Gel (NDC 69804-024-15), 4 oz Liquid Gel (NDC 69804-024-16) bottles, Manufactured by Pain Relief Naturally, www.Naturally HL.com | GMP Deviations: inadequate manufacturing control processes | Ridge Properties, LLC / N/A | Class II | Terminated |
| D-0087-2018 | 11-03-2017 | Extra Strength PreTAT by TAT BALM Gel, (lidocaine HCL 4%), 1/2 oz Gel (NDC 69804-018-09), 1 oz Gel (NDC 69804-018-10) , 2 oz Gel (NDC 69804-018-11), and 4 oz Gel (NDC 69804-018-12) jars, Manufactured by Pain Relief Naturally, www.Naturally HL.com | GMP Deviations: inadequate manufacturing control processes | Ridge Properties, LLC / N/A | Class II | Terminated |
| D-0088-2018 | 11-03-2017 | Extra Strength Naturally HL Hemorrhoid Numbing Spray with Lidocaine, (lidocaine HCL 4%), 1/2 oz Spray (NDC 69804-015-08), 1 oz Spray (NDC 69804-015-07), 2 oz Spray (NDC 69804-015-01) and 4 oz Spray (NDC 69804-015-04) bottles, Manufactured by Pain Relief Naturally, www.Naturally HL.com | GMP Deviations: inadequate manufacturing control processes | Ridge Properties, LLC / N/A | Class II | Terminated |
| D-0230-2018 | 11-03-2017 | bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC: 0378-2009-05 | Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntary recall due to related out of specification compound results obtained during routine stability testing. | Mylan Pharmaceuticals Inc. / 1,414/500 count bottles | Class III | Terminated |
| D-0086-2018 | 11-03-2017 | Extra Strength Naturally HL Bed Sore Relief Cream with Added Lidocaine, (lidocaine HCL 4%), 1/2 oz Balm(NDC 69804-008-06), 1 oz Balm (NDC 69804-008-05), 2 oz Balm(NDC 69804-008-02), and 4 oz Balm(NDC 69804-008-03), Manufactured by Pain Relief Naturally, www.Naturally HL.com | GMP Deviations: inadequate manufacturing control processes | Ridge Properties, LLC / N/A | Class II | Terminated |
| D-0072-2018 | 10-30-2017 | Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol, (lidocaine 4%, menthol 1%), Net Wt. 2.75 oz. (77.3 g) Tube, Distributed by: Ducere Pharma, LLC New Hope, PA 18938 USA --- UPC 849648000023 | Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt match the lot number printed on the bottle | Dr. Reddy's Laboratories, Inc. / 23402 cases | Class III | Terminated |
| D-0220-2018 | 10-30-2017 | ePHEDrine Sulfate In 0.9% Sodium Chloride, 5 mg per mL (50 mg per 10 mL), 10 mL Total Volume pre-filled syringes, packaged in a) 5-count cartons, NDC 71030-0003-10 and NDC 71030-0003-20, and b) 25-count cartons, NDC 71030-0003-21 and NDC 71030-0003-12, Rx Only, PharMEDium Services, LLC, 913 N. Davis Ave, Cleveland, MS, Code 2R3304. | Subpotent Drug | Pharmedium Services, LLC / 5002 syringes | Class II | Terminated |
| D-0082-2018 | 10-30-2017 | Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-122-06 Package NDCs: 59746-122-06; 59746-122-10; 59746-121-06; 59746-121-10 | Marketed without an approved NDA/ANDA: Bottles were released prior to final approval. | Jubilant Cadista Pharmaceuticals, Inc. / 744 bottles | Class III | Terminated |
| D-0152-2018 | 10-27-2017 | Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 76045-001-20 Package NDCs: 76045-211-00; 76045-211-20; 76045-001-00; 76045-001-20; 76045-002-00; 76045-002-10; 76045-003-00; 76045-003-20 | Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL | Fresenius Kabi USA, LLC / 203136 syringes | Class I | Terminated |
| D-0069-2018 | 10-25-2017 | Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-count bottle (NDC 0591-3771-30), b) 90-count bottle (NDC 0591-3771-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. | Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results. | Teva Pharmaceuticals USA / 140,993 bottles | Class II | Terminated |
| D-0079-2018 | 10-25-2017 | Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2), c) 25 G bottle (NDC: 51552-1392-3) and d) 100 G bottle (NDC 51552-1392-5), Rx only, Distributed by Fagron, Inc., 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967 | cGMP Deviations: lack of quality assurance at the API manufacturer. | Fagron, Inc / 934 grams | Class II | Terminated |
| D-0071-2018 | 10-24-2017 | Succinylcholine 20 MG/ML INJ (QUELICIN), 10 ML Vials, Rx only, Distributed by: ACE Surgical Co., Inc., Brockton, MA | Labeling: Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on the labeling of the outer poly bag | Ace Surgical Supply Co., Inc. / 200 vials (25 mislabeled vials) | Class II | Terminated |
| D-0091-2018 | 10-24-2017 | Paroxetine Tablets, USP, 30mg, 100 tablets (10 x 10) , Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Columbus, Ohio 43217, NDC 68084-046-01 Package NDCs: 68084-044-11; 68084-044-01; 68084-044-65; 68084-045-11; 68084-045-01; 68084-046-11; 68084-046-01; 68084-047-11; 68084-047-01 | Presence of Foreign Tablets/Capsules. | Amerisource Health Services / 74 cartons (cartons of 100 individual unit doses) | Class II | Terminated |
| D-0150-2018 | 10-20-2017 | diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg, a) 100-count bottle (NDC 59762-1061-1), b) 1000-count bottle (NDC 59762-1061-2), Rx Only, Distributed by: Greenstone LLC. Peapack, NJ 07977 Package NDCs: 59762-1061-1; 59762-1061-2 | SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent | Pfizer Inc. / 183437 bottles | Class I | Terminated |
| D-0151-2018 | 10-20-2017 | Zoloft (sertraline HCl) tablets 25 mg* 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., NY, NY, 10017 NDC 0049-4960-30 | SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent | Pfizer Inc. / 1972 bottles | Class II | Terminated |
| D-0077-2018 | 10-19-2017 | Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only, packaged in a) 2.5 mL NDC# 0023-9211-03; b) 5 mL (NDC# 0023-9211-05); c) 10 mL (NDC# 0023-9211-10); d) 15 mL (NDC# 0023-9211-15) bottles, Manufactured By: Allergan, Irvine, CA 92612.. Package NDCs: 0023-9211-03; 0023-9211-05; 0023-9211-10; 0023-9211-15 | Failed Impurities/Degradation Specifications. | Allergan Sales, LLC / 715,041 bottles | Class III | Terminated |
| D-0059-2018 | 10-19-2017 | SUCcinylcholine 20 mg per mL, Total Volume 10 mL in single-dose syringe, (SUCcinylcholine 200 mg / 10 ml) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0910-29 | Lack Of Assurance Of Sterility. | SCA Pharmaceuticals, LLC / 1248 syringes | Class II | Terminated |
| D-0062-2018 | 10-19-2017 | fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250 mL) in 0.9% Sodium Chloride 250 mL Bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205. NDC 70004-0231-40 | Lack Of Assurance Of Sterility. | SCA Pharmaceuticals, LLC / 116 bags | Class II | Terminated |
| D-0064-2018 | 10-19-2017 | morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total Volume 100 mL in Single Dose CADD Cassette (Total morphine Dose 100 mg per 100 mL) (NDC 70004-0100-63) b) Total Volume 50 mL in Single Dose Syringe (Total morphine Dose 50 mg / 50 mL) (NDC 70004-0100-22) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 | Lack Of Assurance Of Sterility. | SCA Pharmaceuticals, LLC / a) 60 bag inside rigid translucent plastic case (CADD) b) 238 bag | Class II | Terminated |
| D-0068-2018 | 10-19-2017 | ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5 mL Total Dose) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-850-09 | Lack Of Assurance Of Sterility. | SCA Pharmaceuticals, LLC / 487 syringes | Class II | Terminated |
| D-0061-2018 | 10-19-2017 | HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9% Sodium Chloride 50 mL (HYDROmorphone Total Dose 1000 mcg) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0331-22 | Lack Of Assurance Of Sterility. | SCA Pharmaceuticals, LLC / 60 bags | Class II | Terminated |
| D-0060-2018 | 10-19-2017 | HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill in 30 mL single-dose syringe (Total Dose Hydromorphone 25 mg/25 mL) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0303-17 | Lack Of Assurance Of Sterility. | SCA Pharmaceuticals, LLC / 128 syringes | Class II | Terminated |
| D-0066-2018 | 10-19-2017 | PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL Fill Volume in a Single Dose Syringe (1,000 mcg / 10 ml Total Dose), Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR, NDC 70004-0810-12 | Lack Of Assurance Of Sterility. | SCA Pharmaceuticals, LLC / 1221 syringes | Class II | Terminated |
| D-0067-2018 | 10-19-2017 | Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride 50 mL Bag, Each bag contains 9.3 mEq Ca++ Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0510-30 | Lack Of Assurance Of Sterility. | SCA Pharmaceuticals, LLC / 76 bags | Class II | Terminated |
| D-0065-2018 | 10-19-2017 | oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag, Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0086-44 | Lack Of Assurance Of Sterility. | SCA Pharmaceuticals, LLC / 450 bags | Class II | Terminated |
| D-0063-2018 | 10-19-2017 | fentaNYL as citrate 2 mcg / mL, ROPIVacaine HCl 0.1%, Total Fentanyl Dose (200 mcg per 100 mL) in 0.9% Sodium Chloride single dose CADD Cassette Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0264-64 | Lack Of Assurance Of Sterility. | SCA Pharmaceuticals, LLC / 20 bags inside rigid translucent plastic cases (CADD) | Class II | Terminated |
| D-0078-2018 | 10-19-2017 | Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, Allergan, Irvine, CA 92612. NDC# 0023-3205-03 Package NDCs: 0023-3205-02; 0023-3205-03; 0023-3205-05; 0023-3205-08 | Failed Impurities/Degradation Specifications. | Allergan Sales, LLC / 153,616 bottles | Class III | Terminated |
| D-0052-2018 | 10-17-2017 | Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 0591-5884-01. | Failed Dissolution Specifications: Low out of specification results for dissolution. | Teva Pharmaceuticals USA / 58,292 bottles | Class III | Terminated |
| D-0080-2018 | 10-13-2017 | Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packaged in syringes, Rx Only , PharMEDium Services, LLC. 913 N. Davis Ave Cleveland, MS 38732, NDC 61553-352-40 | Superpotent drug: out of specification result for potency | PharMEDium Services, LLC. / 499 syringes | Class II | Terminated |
| D-0056-2018 | 10-13-2017 | Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: Teva Pharmachemle, Swensweg 5, Haarlem, The Netherlands; Mfd for: Winthrop U.S., a business of sanofi-aventis U.S. LLC, Bridgewater, NJ 08807; NDC 0955-1746-01. | Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection. | Sanofi-Aventis U.S. LLC / 422 vials | Class III | Terminated |
| D-0075-2018 | 10-12-2017 | Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, Rx Only, Mfd. by: Teva Pharmachemie Swensweg 5 Haarlem, The Netherlands Mfd. for: Genzyme Corporation, Cambridge, MA 02142, NDC 0024-5860-01. | Labeling: Incorrect or Missing Package Insert. | Genzyme Corporation / 9,343 single dose vials | Class III | Terminated |
| D-0099-2018 | 10-12-2017 | Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Jeedimetla,Hyderabad - 500 055, India, NDC 31722-574-47 Package NDCs: 31722-574-47 | Presence of foreign substance (screw) | Hetero Labs, Ltd. - Unit III / 4050 bottles | Class II | Terminated |
| D-0021-2018 | 10-10-2017 | Midazolam HCL 100 mg (1mg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025016201 | Lack of Assurance of Sterility. | Banner Pharmacy Services, LLC / 966 cassettes | Class II | Terminated |
| D-0025-2018 | 10-10-2017 | Succinylcholine 200 mg/10 mL Syringe, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025088801 | Lack of Assurance of Sterility. | Banner Pharmacy Services, LLC / 2792 syringes | Class II | Terminated |
| D-0018-2018 | 10-10-2017 | fentanyl citrate (PF) 1100 mcg (20 mcg/mL) 55 mL syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025011001 | Lack of Assurance of Sterility. | Banner Pharmacy Services, LLC / N/A | Class II | Terminated |
| D-0019-2018 | 10-10-2017 | Hydromorphone HCl 10 mg (0.2mg/ml) 50 mL syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025001001. | Lack of Assurance of Sterility. | Banner Pharmacy Services, LLC / 1658 syringes | Class II | Terminated |
| D-0017-2018 | 10-10-2017 | fentaNYL citrate 1000 mcg (10 mcg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025011001 | Lack of Assurance of Sterility. | Banner Pharmacy Services, LLC / 9030 cassetts | Class II | Terminated |
| D-0027-2018 | 10-10-2017 | VANCOmycin 1.25 grams added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025007001 | Lack of Assurance of Sterility. | Banner Pharmacy Services, LLC / 2443 bags | Class II | Terminated |
| D-0016-2018 | 10-10-2017 | ePHEDrine sulfate 50 mg/10 ml syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025024801 | Lack of Assurance of Sterility. | Banner Pharmacy Services, LLC / 972 syringes | Class II | Terminated |
| D-0024-2018 | 10-10-2017 | Ropivacaine HCL (PF) 0.2% (2mg/mL) 100 mL Cassette Rx Only Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226 NDC 7025006301 | Lack of Assurance of Sterility. | Banner Pharmacy Services, LLC / 2173 cassettes | Class II | Terminated |
| D-0020-2018 | 10-10-2017 | Magnesium sulfate 10 Gm added to Lactated Ringer's 250 mL bags, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025003201 | Lack of Assurance of Sterility. | Banner Pharmacy Services, LLC / 7578 bags | Class II | Terminated |
| D-0026-2018 | 10-10-2017 | VANCOmycin 1.5 grams added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025002501 | Lack of Assurance of Sterility. | Banner Pharmacy Services, LLC / 3136 bags | Class II | Terminated |
| D-0023-2018 | 10-10-2017 | OXYtocin 30 units added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025000101 | Lack of Assurance of Sterility. | Banner Pharmacy Services, LLC / 24306 units | Class II | Terminated |
| D-0022-2018 | 10-10-2017 | Norepinephrine Bitartrate 8 mg added to 0.9% Sodium Chloride 250 mL in a bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025011501 | Lack of Assurance of Sterility. | Banner Pharmacy Services, LLC / 3550 bags | Class II | Terminated |
| D-0028-2018 | 10-10-2017 | Norepinephrine Bitartrate16 mg added to 0.9% Sodium Chloride 250 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025014801 | Lack of Assurance of Sterility. | Banner Pharmacy Services, LLC / 481 bags | Class II | Terminated |
| D-0015-2018 | 10-10-2017 | Diltiazem HCL 125 mg added to 0.9% Sodium Chloride 100 ml bag, 125 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025018601 | Lack of Assurance of Sterility. | Banner Pharmacy Services, LLC / 1359 bags | Class II | Terminated |
| D-0055-2018 | 10-06-2017 | Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-283-15. | Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid. | AVKARE Inc. / 274 cartons | Class II | Terminated |
| D-0058-2018 | 10-06-2017 | A1 Slim, Dietary Supplement Beautifully Slim, capsule, 350 mg, 30-count bottle, A1 Slim LLC Pearland TX 77584, www.A1SLIM.COM, [email protected] Bar-Code A105212014 | Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sibutramine, phenolphthalein, and n-desmethyl sibutramine, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall. | Kiriko, LLC. / 700 bottles | Class II | Terminated |
| D-0095-2018 | 10-06-2017 | No.1 Faiza Beauty Cream Manufactured by: Poonia Brothers (Pak), Gujranwala, Distributed by NEW RELIANCE TRADING, INC., 5563 59th St., Maspeth, New York, 11378-2358, UPC 8993138993349, 5842109854239. | Marketed Without an Approved NDA/ANDA | NEW RELIANCE TRADING, INC. / 513 foil packets | Class II | Terminated |
| D-0070-2018 | 10-05-2017 | Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01 Package NDCs: 67618-153-01; 67618-153-03 | Subpotent Drug: The laminate used to make the pouches was reversed such that the aluminum layer was in contact with the product causing an exothermic reaction between the free iodine and the aluminum. | Purdue Pharma, LP / 3997 swabsticks | Class II | Terminated |
| D-0009-2018 | 10-03-2017 | Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CVS Pharmacy Acid Controller, NDC 55111-118-30, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in India, b) Equate Famotidine, NDC 49035-118-30, Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716, Made in India Package NDCs: 55111-118-30; 55111-118-40; 55111-118-60; 55111-118-90; 55111-118-04; 55111-118-18; 55111-118-24; 55111-118-35; 55111-118-81; 55111-118-79; 55111-118-12; 55111-396-35; 55111-396-50; 55111-396-65; 55111-396-90; 55111-396-44; 55111-396-01; 55111-396-13; 55111-396-32; 55111-396-08; 55111-396-16; 49035-118-30 | Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batch for related substances -impurity 8 at 24 month stability interval. | Dr. Reddy's Laboratories, Inc. / 569376 bottles | Class III | Terminated |
| D-0010-2018 | 10-02-2017 | Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured by: UNICHEM LABORATORIES, LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa, 403 511, India, Marketed by: UNICHEM PHARMACEUTICALS, (USA), INC. Hasbrouck Heights, NJ 07604, NDC 29300-126-13. Package NDCs: 29300-126-13; 29300-126-01; 29300-126-05; 29300-127-13; 29300-127-01; 29300-127-05 | Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing. | Unichem Pharmaceuticals Usa Inc / 96,876 bottles | Class II | Terminated |
| D-0085-2018 | 09-28-2017 | Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 NDC 69315-904-05 Package NDCs: 69315-904-01; 69315-904-05; 69315-904-10; 69315-905-01; 69315-905-05; 69315-905-10; 69315-906-01; 69315-906-05; 69315-906-10 | Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam | Leading Pharma, LLC / 2952 500-count bottles | Class II | Terminated |
| D-0008-2018 | 09-27-2017 | Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), Rx Only, For Injection, United Pharmacy Compounded, 13951 N. Haverhill Rd Ste. 120-121 West Palm Beach, FL 33417 | CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed | United Pharmacy / 268 vials | Class II | Terminated |
| D-0212-2018 | 09-27-2017 | FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bulk, b) 40 mg SMT G EP PR KR, c) 20 mg SMT G EP PR, d) 20 mg SMT G EP PR KR, FOR MANUFACTURING, PROCESSING OR REPACKAGING | Microbial Contamination of Non-Sterile Products | Pfizer Manufacturing Deutschland GmbH / a)7387263 tablets; b)5877188 tablets; c)11755825 tablets; d) 5872816 tablets | Class II | Terminated |
| D-0221-2018 | 09-26-2017 | Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0.9% Sodium Chloride 10 mL syringes, PharMEDium Services, LLC 913 N Davis Ave Cleveland, MS, NDC 71019-263-20 | Superpotent Drug | Pharmedium Services, LLC / 2390 syringes | Class II | Terminated |
| D-0132-2018 | 09-26-2017 | HYDROmorphone HCl in 0.9% Sodium Chloride Injection, 1 mL Total Volume 1 mg per mL, For IV Use Only, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-165-78 | Labeling: Incorrect or Missing Lot and/or Exp. Date | Pharmedium Services, LLC / Unknown | Class III | Terminated |
| D-0130-2018 | 09-26-2017 | morphine Sulfate in 0.9% Sodium Chloride Injection 2 mL Total Volume 1 mg per mL (2 mg per 2 mL), For IV Use, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-259-28 | Labeling: Incorrect or Missing Lot and/or Exp. Date | Pharmedium Services, LLC / Unknown | Class III | Terminated |
| D-0131-2018 | 09-26-2017 | morphine Sulfate in 0.9% Sodium Chloride Injection 1 mL Total Volume 2 mg per mL , For IV Use, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-455-78 | Labeling: Incorrect or Missing Lot and/or Exp. Date | Pharmedium Services, LLC / Unknown | Class III | Terminated |
| D-0013-2018 | 09-26-2017 | Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa 403 722 INDIA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-5858-61. | Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity. | The Harvard Drug Group / 3,935 cartons | Class II | Terminated |
| D-0057-2018 | 09-25-2017 | Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per tray, 3 trays per case containing a total of 5 mL x 30 Unit Dose Cups per case (NDC 68094-301-62), Rx only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080. | Subpotent Drug: low out of specification results. | Precision Dose Inc. / 801 cases | Class III | Terminated |
| D-0012-2018 | 09-25-2017 | methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-10 | Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product. | RXQ Compounding LLC / 945 vials | Class II | Terminated |
| D-1438-2019 | 09-25-2017 | Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-171-01 | Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets. | Amneal Pharmaceuticals, Inc. / 19104 units | Class III | Terminated |
| D-1439-2019 | 09-25-2017 | Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-172-01 | Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets. | Amneal Pharmaceuticals, Inc. / 19176 units | Class III | Terminated |
| D-1179-2017 | 09-25-2017 | Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78) packaged in 10-count shrink wrap packs (NDC 0781-3407-95), Rx only, Manufactured in Austria by Sandoz GmbH or Sandoz Inc., Princeton, NJ 08540. Package NDCs: 0781-3400-78; 0781-3400-95; 0781-3402-78; 0781-3402-95; 0781-3407-78; 0781-3407-95; 0781-3404-85; 0781-3404-95; 0781-3408-80; 0781-3408-95 | Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels. | Sandoz Inc / 13,435 shrink wrap packs | Class III | Terminated |
| D-0007-2018 | 09-22-2017 | Mobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Lic. from: BI Int'l GmbH, Made in Italy, NDC 0597-0030-01 | Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert. | Boehringer Ingelheim Pharmaceuticals, Inc. / 128 bottles | Class III | Terminated |
| D-0252-2018 | 09-21-2017 | Aplicare Povidone-Iodine Prep Pad, Antiseptic, Sterile Solution, Active Ingredient: Povidone-iodine USP 10%. Aplicare, INC., Meriden, CT 06450 USA. NDC: 52380-0111-1 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 11,750 cases | Class II | Terminated |
| D-0292-2018 | 09-21-2017 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 100 cases | Class II | Terminated |
| D-0274-2018 | 09-21-2017 | Medline INCISION AND DRAINAGE TRAY Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 60 cases | Class II | Terminated |
| D-0266-2018 | 09-21-2017 | Medline Central Line Dressing Change Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 14,675 cases | Class II | Terminated |
| D-0299-2018 | 09-21-2017 | Medical Equipment Affiliates IV Start Kit, Sterile, Single Use Only. Packaged in Mexico for Medical Equipment Affiliates., Tahlequah, OK 74464 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 5,400 cases | Class II | Terminated |
| D-0298-2018 | 09-21-2017 | Medline IV Start Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 350 cases | Class II | Terminated |
| D-0258-2018 | 09-21-2017 | Medline Concordia Trunk Kit. Packaged for Medline Industries, Inc., Northfield, IL 60093 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 21 cases | Class II | Terminated |
| D-0315-2018 | 09-21-2017 | Medline Incision Drainage Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / | Class II | Terminated |
| D-0311-2018 | 09-21-2017 | Professional Hospital Supply Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Professional Hospital Supply, Inc., 41980 Winchester Rd., Temecula, CA 92590 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 450 cases | Class II | Terminated |
| D-0270-2018 | 09-21-2017 | Medline Wound Closure Tray, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 80 cases | Class II | Terminated |
| D-0314-2018 | 09-21-2017 | Medline Skin Stapler RMVR, Tray Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 592 ases | Class II | Terminated |
| D-0303-2018 | 09-21-2017 | Medline Pacemaker Implant Pack, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 66 cases | Class II | Terminated |
| D-0309-2018 | 09-21-2017 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 98,901 cases | Class II | Terminated |
| D-0308-2018 | 09-21-2017 | Medline Incision and Drainage Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 808 cases | Class II | Terminated |
| D-0317-2018 | 09-21-2017 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 9,000 cases | Class II | Terminated |
| D-0293-2018 | 09-21-2017 | Medline Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 100 cases | Class II | Terminated |
| D-0300-2018 | 09-21-2017 | Medline Debridement Tray, Sterile, Single Use Only. Assembled in USA by Medline Industries, Inc., Mundelein, IL 6060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 90 cases | Class II | Terminated |
| D-0316-2018 | 09-21-2017 | Medline Abdominal Surgery II Pack-LF, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 144 cases | Class II | Terminated |
| D-0265-2018 | 09-21-2017 | Medline IV Start Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 10,375 cases | Class II | Terminated |
| D-0306-2018 | 09-21-2017 | Medline Anesthesia Kit, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Northfield, IL 60093 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 60 cases | Class II | Terminated |
| D-0259-2018 | 09-21-2017 | Medline Concordia Nurse Bag Kit. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 51 cases | Class II | Terminated |
| D-0281-2018 | 09-21-2017 | Medline GHS Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 1100 cases | Class II | Terminated |
| D-0305-2018 | 09-21-2017 | Medline Incision Drainage Kit, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 149 cases | Class II | Terminated |
| D-0318-2018 | 09-21-2017 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 34,495 cases | Class II | Terminated |
