Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0091-2017 | 07-17-2015 | lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 3 mL in a syringe, Rx only, PharMEDium, Product code 2R3343. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 4400 syringes | Class II | Terminated |
| D-0048-2017 | 07-17-2015 | HEPARIN Sodium Inj., USP, 5,000 USP Heparin Units per 5 mL Total Volume in a syringe, NOT FOR LOCK FLUSH, 1,000 USP Heparin Units per mL, Rx only, PharMEDium, Product code 2K1925. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 240 syringes | Class II | Terminated |
| D-0051-2017 | 07-17-2015 | HYDROmorphone HCl, 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3352. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 4860 syringes | Class II | Terminated |
| D-0032-2017 | 07-17-2015 | Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium Chloride, Total Dose 25.005 mcg/1.5 mL Fentanyl Citrate, Content Volume 1.5 mL in 3 mL BD Syringe, Intended for Epidural Use, Rx only, PharMEDium, Product code 2T6228. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 210 syringes | Class II | Terminated |
| D-0039-2017 | 07-17-2015 | fentaNYL Citrate, 5 mcg per mL, 15 mcg per 3mL, in 0.9% Sodium chloride, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3318. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 1522 syringes | Class II | Terminated |
| D-0062-2017 | 07-17-2015 | lidocaine HCl, 1%, 10 mg per mL (50 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3106. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 499 syringes | Class II | Terminated |
| D-0077-2017 | 07-17-2015 | morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3119. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 935 syringes | Class II | Terminated |
| D-0052-2017 | 07-17-2015 | HYDROmorphone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2T6165 | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 450 syringes | Class II | Terminated |
| D-0037-2017 | 07-17-2015 | fentaNYL Citrate Injection, 50 mcg per mL (100 mcg per 2 mL), 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3303. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 53357 syringes | Class II | Terminated |
| D-0076-2017 | 07-17-2015 | morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 1 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3017. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 3270 syringes | Class II | Terminated |
| D-0058-2017 | 07-17-2015 | labetalol HCl, 5 mg per mL, 20 mg per 4 mL, 4 mL total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3117. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 969 syringes | Class II | Terminated |
| D-0056-2017 | 07-17-2015 | ketamine HCl Injection, 50 mg per mL, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3348. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 12,173 syringes | Class II | Terminated |
| D-0046-2017 | 07-17-2015 | glycopyrrolate, 0.2 mg per mL, 1 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3340. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 1494 syringes | Class II | Terminated |
| D-0074-2017 | 07-17-2015 | midazolam HCl, 1 mg per mL (3 mg per 3 mL), in 0.9% Sodium Chloride, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product Code 2R3351. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 4058 syringes | Class II | Terminated |
| D-0034-2017 | 07-17-2015 | fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3153. | Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 4347 syringes | Class II | Terminated |
| D-0044-2017 | 07-17-2015 | glycopyrrolate, 0.2 mg per mL, 0.6 mg per 3 mL, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3217. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 16366 syringes | Class II | Terminated |
| D-0081-2017 | 07-17-2015 | morphine Sulfate, 2 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2T6455. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 25 syringes | Class II | Terminated |
| D-0055-2017 | 07-17-2015 | ketamine HCl, 10 mg per mL, 20 mg per 2 mL, in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3330. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 9101 syringes | Class II | Terminated |
| D-0078-2017 | 07-17-2015 | morphine Sulfate, 1 mg per mL (5 mg per 5 mL), in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 5 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3181. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 592 syringes | Class II | Terminated |
| D-0075-2017 | 07-17-2015 | midazolam HCl, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3356. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 26079 syringes | Class II | Terminated |
| D-0027-2017 | 07-17-2015 | Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 660 syringes | Class II | Terminated |
| D-0083-2017 | 07-17-2015 | neostigmine Methylsulfate, 1 mg per mL, 2 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3550. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 250 syringes | Class II | Terminated |
| D-0067-2017 | 07-17-2015 | lidocaine HCl 2%, Preservative Free, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3384. | Stability Data Does Not Support Expiry:potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 512 syringes | Class II | Terminated |
| D-0089-2017 | 07-17-2015 | rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3321. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 6970 syringes | Class II | Terminated |
| D-0061-2017 | 07-17-2015 | lidocaine HCl, 1%, 30 mg per 3 mL, 3 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3104. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 500 syringes | Class II | Terminated |
| D-0072-2017 | 07-17-2015 | methadone HCl, 10 mg per mL, 1 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6149. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 7556 syringes | Class II | Terminated |
| D-0069-2017 | 07-17-2015 | lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3450. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 3159 syringes | Class II | Terminated |
| D-0082-2017 | 07-17-2015 | neostigmine Methylsulfate, 1 mg per mL, 5 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3326. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 21053 syringes | Class II | Terminated |
| D-0049-2017 | 07-17-2015 | HEPARIN Sodium Inj. USP, 3,000 USP Heparin Units per 3 mL Total Volume in a syringe, NOT FOR LOCK FLUSH, 1,000 Heparin USP Units per mL, Rx only, PharMEDium, Product code 2K1926. | Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 350 syringes | Class II | Terminated |
| D-0050-2017 | 07-17-2015 | HYDROmorphone HCl, 0.2 mg per mL, (0.4 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3162. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 1916 syringes | Class II | Terminated |
| D-0054-2017 | 07-17-2015 | ketamine HCl, 10 mg per mL, 50 mg per 5 mL, 0.9% Sodium Chloride, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3320. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 1500 syringes | Class II | Terminated |
| D-0040-2017 | 07-17-2015 | fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3339. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 1561 syringes | Class II | Terminated |
| D-0073-2017 | 07-17-2015 | midazolam HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3196. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 1700 syringes | Class II | Terminated |
| D-0068-2017 | 07-17-2015 | lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume, Product code 2R3441, NDC 61553-441-80 | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 1161 syringes | Class II | Terminated |
| D-0092-2017 | 07-17-2015 | lidocaine HCl, 2%, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3110. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 499 syringes | Class II | Terminated |
| D-0029-2017 | 07-17-2015 | ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3301. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 995 syringes | Class II | Terminated |
| D-0033-2017 | 07-17-2015 | fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Product code 2R3118, NDC 61553-118-40 | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 50 syringes | Class II | Terminated |
| D-0085-2017 | 07-17-2015 | PHENYLephrine HCl, 40 mcg per mL, 200 mcg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3376. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 380 syringes | Class II | Terminated |
| D-1345-2015 | 07-17-2015 | buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, Manufactured By: Sun Pharmaceutical Ind. Ltd., Halol Baroda Highway, Halol 389 350, Gujarat, India, NDC 47335-738-86 Package NDCs: 47335-736-86; 47335-736-88; 47335-736-08; 47335-736-13; 47335-737-86; 47335-737-88; 47335-737-08; 47335-737-13; 47335-738-86; 47335-738-88; 47335-738-08; 47335-738-13 | Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications. | Sun Pharma Global Fze / 35,235 bottles | Class III | Terminated |
| D-0785-2016 | 07-16-2015 | Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg DONNATAL ELIXIR, 5 ml Cup grape, Alcohol 23.8%, Rx Only, MFG: Concordia, PKG BY: SAFECOR HEALTH, WOBURN, MA, C5921242304. | Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml. | Safecor Health, LLC / 23 cups | Class II | Terminated |
| D-1424-2015 | 07-16-2015 | Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-913-01 | Chemical Contamination; benzophenone leached from the product label varnish | Mutual Pharmaceutical Company, Inc. / 14,112 bottles | Class III | Terminated |
| D-1425-2015 | 07-16-2015 | Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-914-01 | Chemical Contamination; benzophenone leached from the product label varnish | Mutual Pharmaceutical Company, Inc. / 10,080 bottles | Class III | Terminated |
| D-1423-2015 | 07-16-2015 | Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 54738-912-01 | Chemical Contamination; benzophenone leached from the product label varnish | Mutual Pharmaceutical Company, Inc. / 5472 bottles | Class III | Terminated |
| D-1420-2015 | 07-16-2015 | Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-368-01 | Chemical Contamination; benzophenone leached from the product label varnish | Mutual Pharmaceutical Company, Inc. / 25,272 bottles | Class III | Terminated |
| D-1422-2015 | 07-16-2015 | Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co Inc., Philadelphia, PA --- NDC 53489-370-01 | Chemical Contamination; benzophenone leached from the product label varnish | Mutual Pharmaceutical Company, Inc. / 63,975 bottles | Class III | Terminated |
| D-1421-2015 | 07-16-2015 | Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-369-01 | Chemical Contamination; benzophenone leached from the product label varnish | Mutual Pharmaceutical Company, Inc. / 97,859 bottles | Class III | Terminated |
| D-1323-2015 | 07-15-2015 | SENSODYNE EXTRA FRESH REPAIR & PROTECT, 3.4 oz. (96.4 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0547-02 Package NDCs: 0135-0548-02; 0135-0548-01; 0135-0547-02; 0135-0575-01 | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. | GlaxoSmithkline Consmer Healthcare / 335,676 tubes | Class II | Terminated |
| D-1319-2015 | 07-15-2015 | biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT , 4.3 oz.(121.9 g) tubes, Manufactured by Oratech, South Jordan, UTAH, 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108 NDC 0135-0558-01 Package NDCs: 0135-0557-01; 0135-0557-02; 0135-0558-01 | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. | GlaxoSmithkline Consmer Healthcare / 111,892 tubes | Class II | Terminated |
| D-1322-2015 | 07-15-2015 | SENSODYNE COMPLETE PROTECTION, 3.4 oz. (96.4 g)tubes, Manufactured by Oratech, South Jordan UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0573-02 Package NDCs: 0135-0573-02; 0135-0573-03; 0135-0572-02; 0135-0572-03 | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. | GlaxoSmithkline Consmer Healthcare / 81,376 tubes | Class II | Terminated |
| D-1318-2015 | 07-15-2015 | biotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original, a) 0.70 oz (19.8 g) tubes., (NDC 0135-0557-02) , b) 0.75 oz. (21.3 g) tubes, (NDC 0135-0487-02), c) 4.3 oz. (121.9 g) tubes, (NDC 0135-0557-01), d) 4.5 oz. (127.6 g) tubes, (NDC 0135-0487-01), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108 Package NDCs: 0135-0557-01; 0135-0557-02; 0135-0558-01; 0135-0487-02; 0135-0487-01 | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. | GlaxoSmithkline Consmer Healthcare / 366,192 tubes | Class II | Terminated |
| D-1324-2015 | 07-15-2015 | SENSODYNE WITH FLUORIDE REPAIR & PROTECT, a) 0.8 oz.(23 g) tubes, (NDC 0135-0548-01); b) 3.4 oz. (96.4 g) tubes, (NDC 0135-0548-02) Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108 Package NDCs: 0135-0548-02; 0135-0548-01; 0135-0547-02; 0135-0575-01 | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. | GlaxoSmithkline Consmer Healthcare / 325,504 tubes | Class II | Terminated |
| D-1320-2015 | 07-15-2015 | biotene PBF Toothpaste (Plaque-Biofilm Loosening Formula), a) 4.3 oz. (121.9 g) tubes, (NDC 0135-0559-01), biotene¿ PBF Paste, b) 4.5 oz.(127.6 g) tubes, (NDC 0135-0490-02), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108 | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. | GlaxoSmithkline Consmer Healthcare / 50,860 tubes | Class II | Terminated |
| D-1317-2015 | 07-15-2015 | biotene Gentle Mint Gel, 4.5 oz.(127.6 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0488-01 | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. | GlaxoSmithkline Consmer Healthcare / 30,516 tubes | Class II | Terminated |
| D-1321-2015 | 07-15-2015 | SENSODYNE EXTRA FRESH COMPLETE PROTECTION, 3.4 oz.(96.4 g) tubes, Manufactured by Oratech, South Jordan UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0572-02 Package NDCs: 0135-0573-02; 0135-0573-03; 0135-0572-02; 0135-0572-03 | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. | GlaxoSmithkline Consmer Healthcare / 50,860 tubes | Class II | Terminated |
| D-1371-2015 | 07-14-2015 | Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC 10702-0026-01; UPC 3 10702 02601 8) and b) 1000-count bottle (NDC 10702-0026-10; UPC 3 10702 02601 0); Rx only, Mfd. by KVK-TECH, Inc., Newtown, PA | Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station | KVK-Tech, Inc. / 9,696 bottles (100-count), 972 bottles (1000-count) | Class III | Terminated |
| D-1286-2015 | 07-13-2015 | Mometasone Furoate Ointment USP, 0.1%, 15 g tubes, Rx Only, Manufactured by Perrigo, Yeruham 80500, Israel, Distributed by Perrigo, Allegan, MI 49010, NDC 45802-0119-37 | Subpotent drug | Perrigo Israel Pharmaceuticals / 158,268 tubes | Class III | Terminated |
| D-1278-2015 | 07-13-2015 | Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch, 30 pouches per carton, Rx only, Distributed by Purdue Pharma L.P. Stamford, CT 06901-3431, NDC 59011-265-30 | Failed dissolution specifications | Purdue Pharma L.P. / 6,264 cartons (30 sublingual tablets in 1 carton) | Class III | Terminated |
| D-0664-2016 | 07-13-2015 | Akttive High Performance Fat Burner Gold dietary supplement capsules, 30-count bottle, Distributed by Life and More, L.L.C., Doral, Florida | Marketed Without An Approved NDA/ANDA: Dietary supplements contains undeclared sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling. | Life and More LLC / 783 bottles | Class I | Ongoing |
| D-0559-2016 | 07-10-2015 | Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottles, Rx only, Packaged by PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, MFG: Mutual Pharm. Co. Inc., Philadelphia, PA 19124, NDC 43063-509-01 | cGMP Deviations | PD-Rx Pharmaceuticals, Inc. / 9 bottles | Class II | Terminated |
| D-1280-2015 | 07-09-2015 | Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 53489-215-01) and b) 1000 count (NDC 53489-215-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA | cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer | Mutual Pharmaceutical Company, Inc. / a) 96,640 bottles; b) 17,808 bottles | Class II | Terminated |
| D-1282-2015 | 07-09-2015 | Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA, NDC 53489-217-01 | cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer | Mutual Pharmaceutical Company, Inc. / 20,892 bottles | Class II | Terminated |
| D-1281-2015 | 07-09-2015 | Clonidine Hydrochloride Tablets, USP, 0.2 mg, packaged in a) 100 count (NDC 53489-216-01) and b) 1000 count (NDC 53489-216-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA. | cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer | Mutual Pharmaceutical Company, Inc. / a) 39,036 bottles and b) 2,082 bottles | Class II | Terminated |
| D-1236-2015 | 07-07-2015 | Nitroglycerin Transdermal System 0.2 mg/hr (10 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: Kremers Urban Pharmaceuticals Inc., Princeton, NJ, 08540, USA, By LTS Lohmann Therapie Systeme AG, Anderach, Federal Republic of Germany, NDC 62175-123-01 | Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24 month stability testing. | Kremers Urban Pharmaceuticals, Inc. / 16,832 Boxes | Class II | Terminated |
| D-1237-2015 | 07-07-2015 | Nitroglycerin Transdermal System 0.4 mg/hr (18 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: Kremers Urban Pharmaceuticals Inc., Princeton, NJ, 08540, USA, By LTS Lohmann Therapie Systeme AG, Anderach, Federal Republic of Germany, NDC 62175-124-01 | Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing. | Kremers Urban Pharmaceuticals, Inc. / 16,504 Boxes | Class II | Terminated |
| D-1233-2015 | 07-06-2015 | Maximum Strength Analgesic Thera-Gesic Pain Relieving Creme Relief from: Joint and Muscle Soreness, Arthritis, Back Aches; 1/8 Oz Sachet, OTC, Manufactured for Mission Pharmacal Company 10999 IH 10 West, Suite 1000 San Antonio, TX 78230 by Mission Pharmacal Company 38505 IH 10 West Boerne, TX 78006. NDC 0178-0320-12 | Subpotent Drug: menthol and methyl salicylate below specification | BioComp Pharma, Inc. / 40,000 sachets | Class III | Terminated |
| D-1240-2015 | 07-02-2015 | 0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira, Inc., Ausitn, TX 78728, NDC 00409-7101-68 | Lack of assurance of sterility: Potential channel leaks near the threaded vial port. | Hospira Inc. / 314600 bags | Class II | Terminated |
| D-1165-2016 | 07-02-2015 | Zero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distributed by Xtreme Z Distributors, Inc., Miami, FL 33180 | Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine. | XTREME Z DISTRIBUTORS INC / 70,350 capsules | Class I | Ongoing |
| D-1419-2015 | 07-02-2015 | CVS SUGAR FREE BLACK CHERRY COUGH DROPS (MENTHOL-COUGH SUPPRESSANT), Packaged in a) 25 Drop Bags (UPC: 050428 448526) and b) 36 drop bags (UPC: 050428 476581), Over the Counter. Distributed by: CVS Pharmacy, Inc., One CVS Drive Woonsocket, RI 02895. | Presence of Foreign Tablets/Capsules: Presence of comingled Sugar Free Honey Lemon cough drops. | Bestco, Inc. / a) 149,856 Bags; b) 19,200 Bags. | Class III | Terminated |
| D-1326-2015 | 07-02-2015 | 0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation Deerfield, IL 60015, 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 | Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky containers, and missing port protectors. | Baxter Healthcare Corp. / 189,912 containers | Class II | Terminated |
| D-1242-2015 | 06-30-2015 | KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3796-01 ---- ALSO labeled under NOVAPLUS label NDC 0409-3796-49 Package NDCs: 0409-3793-19; 0409-3793-01; 0409-3793-25; 0409-3795-19; 0409-3795-01; 0409-3795-25; 0409-3796-19; 0409-3796-01; 0409-3796-25; 0409-3796-49 | Crystallization; identified as calcium salt of Ketorolac | Hospira Inc. / 5,214,900 vials (Hospira label); 250,600 vials (NOVAPLUS label) | Class II | Ongoing |
| D-1241-2015 | 06-30-2015 | KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49 Package NDCs: 0409-3793-19; 0409-3793-01; 0409-3793-25; 0409-3795-19; 0409-3795-01; 0409-3795-25; 0409-3796-19; 0409-3796-01; 0409-3796-25; 0409-3795-49 | Crystallization; identified as calcium salt of Ketorolac | Hospira Inc. / 12,460,975 vials(Hospira label); 3,016,500 vials (NOVAPLUS label) | Class II | Ongoing |
| D-1217-2015 | 06-30-2015 | Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2512-78, UPC 3 0378-2512-78 6. | Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point. | Mylan Pharmaceuticals Inc / 1068 bottles | Class II | Terminated |
| D-1287-2015 | 06-30-2015 | Panadol (acetaminophen) Extra Strength, 500 mg, a) 30 count (UPC 1-03-53100-91070-8, NDC 0135-0135-02), b) 60 count (UPC 1-03-53100-91080-7, NDC 0135-0135-03) and c) 100 count (UPC 1-03-53100-91090-6, NDC 0135-0135-04) bottles, Distributed by: GlaxoSmithKline Consumer Healthcare L.P, Moon Township, PA 15108 | Failed Dissolution Specifications | GlaxoSmithkline Consmer Healthcare / 17,675 cases | Class III | Terminated |
| D-1239-2015 | 06-29-2015 | HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968-21), 500 count (NDC 0603-3968-28) and 1000 count (NDC 0603-3968-32) bottles, Manufactured for Qualitest Pharmaceuticals, Huntsville, AL | Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable | Qualitest Pharmaceuticals / 47,376 bottles | Class III | Terminated |
| D-1308-2015 | 06-26-2015 | SIU-Tri-Mix 30/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-2196-10 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 67.5 mL | Class II | Terminated |
| D-1311-2015 | 06-26-2015 | SIU-Tri-Mix 30/1/20 Injectable, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135,NDC 99999-2011-17 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 113 mL | Class II | Terminated |
| D-1302-2015 | 06-26-2015 | SIU-Tri-Mix 17/0.6/5.7 Injectable, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-2348-22 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 5 mL | Class II | Terminated |
| D-1298-2015 | 06-26-2015 | SIU-Papav/Phent 30/1 mg Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-6830-10 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 55 mL | Class II | Terminated |
| D-1294-2015 | 06-26-2015 | SIU-Papaverine 30 mg/mL Inj., Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1775-10 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 32.5 mL | Class II | Terminated |
| D-1300-2015 | 06-26-2015 | SIU-Phent .8/PGE1 20 mcg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-2557-43 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 10 mL | Class II | Terminated |
| D-1305-2015 | 06-26-2015 | SIU-Tri-Mix 18/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-1540-18 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 555.5 mL | Class II | Terminated |
| D-1301-2015 | 06-26-2015 | SIU-Prostaglandin E1 20 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-3169-01 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 163 mL | Class II | Terminated |
| D-1309-2015 | 06-26-2015 | SIU-Tri-Mix 30/2/20 Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1398-47 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 75 mL | Class II | Terminated |
| D-1310-2015 | 06-26-2015 | SIU-Tri-Mix 24 mg/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13389-1152-36 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 55 mL | Class II | Terminated |
| D-1295-2015 | 06-26-2015 | SIU-Papav/Phent 24/1 mg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1461-57 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.. | The Apothecary Shoppe LLC / 20 mL | Class II | Terminated |
| D-1290-2015 | 06-26-2015 | S-Chorionic Gonad HCG 1000 U/mL Injection, Rx Only, 4 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-1968-80 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 98 mL | Class II | Terminated |
| D-1293-2015 | 06-26-2015 | SIH-Testosterone Cyp. 20 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13452-2896-05 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 23 mL | Class II | Terminated |
| D-1235-2015 | 06-26-2015 | Desmopressin Acetate Tablets, 0.1 mg Tablets, Rx Only, Packed in 30 Tablet (3 x 10) Cartons. Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217. NDC: 68084-606-21. | Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side. | American Health Packaging / 341 Cartons | Class III | Terminated |
| D-1299-2015 | 06-26-2015 | SIU-Papav/Phentol 30/.5 mg/mL Injection, Rx Only, 3 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1775-01 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 2.5 mL | Class II | Terminated |
| D-1289-2015 | 06-26-2015 | S-Methylcobalamin 1000 mcg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-1962-40 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 64 mL | Class II | Terminated |
| D-1313-2015 | 06-26-2015 | SIU-Prostaglandin E1 500 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / N/A | Class II | Terminated |
| D-1291-2015 | 06-26-2015 | SIH-Testosterone Cyp. 200 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2829-34 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 1200.4 mL | Class II | Terminated |
| D-1303-2015 | 06-26-2015 | SIU-Tri-Mix 18/1/20 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1563-48 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 55 mL | Class II | Terminated |
| D-1315-2015 | 06-26-2015 | SIH-Hydroxyprogesterone Caproate 250, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 34 mL | Class II | Terminated |
| D-1304-2015 | 06-26-2015 | SIU-Tri-Mix 6/0.33/3.33 Injection Solution, Rx Only, 3 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2007-70 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 2.5 mL | Class II | Terminated |
| D-1296-2015 | 06-26-2015 | SIU-Papav/Phentol 30/1 mg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-6830-10 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 70 mL | Class II | Terminated |
| D-1306-2015 | 06-26-2015 | SIU-Tri-Mix 20/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13452-2913-85 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 10 mL | Class II | Terminated |
| D-1307-2015 | 06-26-2015 | SIU-Tri-Mix 24/1/20 Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1747-39 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 5 mL | Class II | Terminated |
| D-1312-2015 | 06-26-2015 | SO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apothecary Shoppe, Compounding Pharmacy, Tulsa, OK 74135, NDC 13452-2774-94 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 40 mL | Class II | Terminated |
| D-1831-2015 | 06-26-2015 | METOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, 10 mL cups, Rx only. Manufactured by VistaPharm, Inc, Largo, FL. NDC: 66689-031-01. | Defective Container: Lids on unit dose cups are not fully qualified. | VistaPharm, Inc. / 84,100 Cups | Class III | Terminated |
