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-0065-2016 | 07-24-2015 | CHORIONIC GONADOTROPIN, Injectable Solution, 5000 UNITS/0.1 mL, vial sizes: 5 mL; 6 mL; 8 mL; 10 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 9 (5mL) vials, 2 (6mL) vials, 8 (8mL) vials, 2 (10mL) vials | Class II | Terminated |
| D-0142-2016 | 07-24-2015 | TESTOSTERONE CYPIONATE FOR SUBQ INJECTION, Injectable Solution, 100 mg/mL, 10mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 1 syringe | Class II | Terminated |
| D-0117-2016 | 07-24-2015 | PROGESTERONE, Pellet, 200 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 5 pellets | Class II | Terminated |
| D-0075-2016 | 07-24-2015 | DIHYDROERGOTAMINE MESYLATE, Injectable Solution, 1 MG/ML, 20 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 8 syringes | Class II | Terminated |
| D-1348-2015 | 07-24-2015 | univasc (moexipril HCl) tablets, 7.5 mg, 100 Ct Bottle, Rx Only. Manufactured for UCB, Inc., Smyrna, GA 30080. NDC: 0091-3707-01. | Failed Dissolution Testing: Failed 24 month dissolution testing. | Ucb, Inc / 2,916 Bottles | Class II | Terminated |
| D1834-2015 | 07-21-2015 | Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg, 500-count bottles, Rx Only, Apotex Corp. Manufactured by Apotex Research Private Limited, Bangalore, Karnataka 560 099, India; Manufactured for: Apotex Corp., Weston, FL 33326. NDC 60505-2742-5. | Failed Dissolution Specification: One lot of product did not meet the first stage dissolution specification limits. | Apotex Inc. / 2,075 bottles | Class III | Terminated |
| D-1428-2015 | 07-21-2015 | Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res. Flowstop in Sodium Chloride 0.9%, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-834-48 | Lack of Assurance of Sterility: The firm received a complaint of a sterility failure using a non-validated sterility test on a medication cassette. | Pharmedium Services, LLC / 120 cassettes | Class II | Terminated |
| D-0574-2016 | 07-21-2015 | Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 7-count (NDC 55289-791-07), b) 14-count (NDC 55289-791-14), c) 28-count (NDC 55289-791-28), d) 30-count (NDC 55289-791-30), and e) 60-count (NDC 55289-791-60) bottles, Packaged by PD-RX Pharmaceuticals, INC Oklahoma City, OK 73127, MFG: KVK-TECH, INC Newtown, PA 18840. Package NDCs: 55289-791-07; 55289-791-14; 55289-791-15; 55289-791-21; 55289-791-28; 55289-791-30; 55289-791-60 | Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station | PD-Rx Pharmaceuticals, Inc. / 1685 bottles | Class III | Terminated |
| D-1405-2015 | 07-20-2015 | ALLOPURINOL TABLETS, USP, 300 mg, 500 count bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 --- NDC 0603-2116-28 Package NDCs: 0603-2115-93; 0603-2115-21; 0603-2115-28; 0603-2115-32; 0603-2115-02; 0603-2115-04; 0603-2116-02; 0603-2116-21; 0603-2116-28; 0603-2116-32 | Failed Tablet/Capsule Specifications; report of oversized and discolored tablets | Qualitest Pharmaceuticals / 21552 units | Class III | Terminated |
| D-1335-2015 | 07-17-2015 | 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, Product Code 2B0043, NDC 0338-0553-18. Package NDCs: 0338-0553-11; 0338-0553-18 | Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled. | Baxter Healthcare Corp. / 133,600 bags | Class I | Terminated |
| D-1336-2015 | 07-17-2015 | 0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B1301, NDC 0338-0049-11. 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: Customer complaint for an insect found free floating inside a single bag for each lot recalled. | Baxter Healthcare Corp. / 189,120 bags | Class I | Terminated |
| D-0038-2017 | 07-17-2015 | fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL, 5mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3306. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 997 syringes | Class II | Terminated |
| D-0042-2017 | 07-17-2015 | fentaNYL Citrate, 5 mcg per mL, 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3479. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 1735 syringes | Class II | Terminated |
| D-0066-2017 | 07-17-2015 | lidocaine HCl, 2%, Preservative Free, Total Volume 2mL, Product code 2R3323, NDC 61553-323-79 | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 830 syringes | Class II | Terminated |
| D-0053-2017 | 07-17-2015 | ketamine HCl, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3234. | 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-0036-2017 | 07-17-2015 | fentaNYL Citrate, 25 mcg per mL in 0.9% Sodium chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3236. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 110 syringes | Class II | Terminated |
| D-0031-2017 | 07-17-2015 | ePHEDrine Sulfate, 10 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 2R3347. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 1545 syringes | Class II | Terminated |
| D-0064-2017 | 07-17-2015 | lidocaine HCl 1%, 10 mg per mL (50 mg per 5 mL), Preservative Free, 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3391. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 300 syringes | Class II | Terminated |
| D-0093-2017 | 07-17-2015 | fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3174. | Subpotent Drug: confirmed subpotency in one lot of this product that was packaged and stored in syringes. | Pharmedium Services, LLC / 500 syringes | Class I | Terminated |
| D-0047-2017 | 07-17-2015 | HEPARIN Sodium Inj. USP, 15,000 USP Heparin Units per 3 mL Injection 3 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2K1210. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 399 syringes | Class II | Terminated |
| D-0026-2017 | 07-17-2015 | atropine Sulfate Injection, 0.4 mg per mL, 0.8 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3335. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 5568 syringes | Class II | Terminated |
| D-0063-2017 | 07-17-2015 | lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 1 mL in a syringe, Rx only, PharMEDium, Product code 2R3345. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 5900 syringes | Class II | Terminated |
| D-0084-2017 | 07-17-2015 | neostigmine Methylsulfate, 1 mg per mL, 3 mg per 3 mL, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3551. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 700 syringes | Class II | Terminated |
| D-0041-2017 | 07-17-2015 | fentaNYL Citrate, 10 mcg per mL (25 mcg per 2.5 mL), in 0.9% Sodium Chloride, 2.5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3424. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 616 syringes | Class II | Terminated |
| D-0086-2017 | 07-17-2015 | PHENYLephrine HCl, 100 mcg per mL, 0.5 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 2R3109. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 498 syringes | Class II | Terminated |
| D-0028-2017 | 07-17-2015 | Buffered Lidocaine, 2%, In Sodium Bicarbonate 8.4%, 3 mL Total Volume in a syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2475. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 10 syringes | Class II | Terminated |
| D-0071-2017 | 07-17-2015 | methadone HCl, 2.5 mg per 0.5 mL, in 0.9% Sodium Chloride, 0.5 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6134. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 200 syringes | Class II | Terminated |
| D-0080-2017 | 07-17-2015 | morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preservative Free, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3353. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 545 syringes | Class II | Terminated |
| D-0090-2017 | 07-17-2015 | succinylcholine Chloride Injection, 20 mg per mL, 100 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3357. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 2495 syringes | Class II | Terminated |
| D-0070-2017 | 07-17-2015 | methadone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6120. | Stability Data Does Not Support Expiry:potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 7006 syringes | Class II | Terminated |
| D-0088-2017 | 07-17-2015 | remifentanil HCl, 50 mcg per mL, 100 mcg per 2 mL, in 0.9% Sodium Chloride, Preservative Free, 2 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3300. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 1623 syringes | Class II | Terminated |
| D-0045-2017 | 07-17-2015 | glycopyrrolate, 0.2 mg per mL, 0.4 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3329. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 17462 syringes | Class II | Terminated |
| D-0043-2017 | 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 3 mL BD Syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6107. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 10 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-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-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-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-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-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-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-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-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-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-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-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-0025-2017 | 07-17-2015 | atropine Sulfate Injection, 0.4 mg per mL, 1 mg per 2.5 mL, 2.5 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3324. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 4407 syringes | Class II | Terminated |
| 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-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-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-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-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-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-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-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-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-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-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-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-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-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-0060-2017 | 07-17-2015 | lidocaine HCl, 1%, 10 mg per 1 mL, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3102. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 2961 syringes | Class II | Terminated |
| D-0035-2017 | 07-17-2015 | fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3174. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 8955 syringes | Class II | Terminated |
| D-0030-2017 | 07-17-2015 | ePHEDrine Sulfate, 10 mg per mL, 50 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 2R3308. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 1478 syringes | Class II | Terminated |
| D-0057-2017 | 07-17-2015 | ketamine HCl Injection, 50 mg per mL (100 mg per 2 mL), 2 mL Total Volume in a syringe, Rx only, PharMEDium, For IV Use, Product code 2R3500. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 54 syringes | Class II | Terminated |
| D-0079-2017 | 07-17-2015 | morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 2 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3259. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 21506 syringes | Class II | Terminated |
| D-0087-2017 | 07-17-2015 | PHENYLephrine HCl, 100 mcg per mL, 0.5 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 2R3346. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 2985 syringes | Class II | Terminated |
| D-0065-2017 | 07-17-2015 | lidocaine HCl, 2%, 40 mg per 2 mL, 2 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3112. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 6324 syringes | Class II | Terminated |
| D-0059-2017 | 07-17-2015 | lidocaine HCl, 0.5%, 5 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3140. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 3285 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
