Drug recalls
Enforcement reports from the FDA's weekly recall database. Recalls are classified by the health hazard the defect presents: Class I where exposure is reasonably likely to cause serious harm or death, Class II where it may cause temporary or reversible harm, and Class III where it is unlikely to cause harm.
17,975 records · source: openFDA Enforcement
All classes 17,975 Class II 14,511 Class I 1,747 Class III 1,715 Not Yet Classified 2
| Class | Reported | Product | Reason | Firm | Status |
|---|---|---|---|---|---|
| Class II | October 19, 2016 | morphine Sulfate, 2 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe,… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | glycopyrrolate, 0.2 mg per mL, 0.6 mg per 3 mL, 3 mL Total Volume in a syringe, For IV… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class I | October 19, 2016 | Oasis Dietary Supplement Capsules, 500 mg, 45 count bottles, Manufactured for Timeless… | Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein | Bee Xtreme | Terminated |
| Class II | October 19, 2016 | morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free (Contains… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | labetalol HCl, 5 mg per mL, 20 mg per 4 mL, 4 mL total Volume in a syringe, For IV Use,… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | ketamine HCl Injection, 50 mg per mL, 1 mL Total Volume in a syringe, For IV Use, Rx… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2… | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters | Leiter's Compounding | Terminated |
| Class II | October 19, 2016 | midazolam HCl, 1 mg per mL (3 mg per 3 mL), in 0.9% Sodium Chloride, 3 mL Total Volume in… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a… | Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency in drugs… | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | glycopyrrolate, 0.2 mg per mL, 1 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use,… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured in Hungary… | CGMP Deviations | Teva Pharmaceuticals USA | Terminated |
| Class II | October 19, 2016 | fentaNYL Citrate Injection, 50 mcg per mL (100 mcg per 2 mL), 2 mL Total Volume in a… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL Total Volume… | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters | Leiter's Compounding | Terminated |
| Class II | October 19, 2016 | methadone HCl, 10 mg per mL, 1 mL Total Volume in a syringe, For IV Use Only, Rx only,… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | lidocaine HCl, 1%, 30 mg per 3 mL, 3 mL Total Volume in a syringe, Rx only, PharMEDium,… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume in a syringe, Rx… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | HEPARIN Sodium Inj. USP, 3,000 USP Heparin Units per 3 mL Total Volume in a syringe, NOT… | Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency in drugs… | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | neostigmine Methylsulfate, 1 mg per mL, 5 mg per 5 mL, 5 mL Total Volume in a syringe,… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | HYDROmorphone HCl, 0.2 mg per mL, (0.4 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | ketamine HCl, 10 mg per mL, 50 mg per 5 mL, 0.9% Sodium Chloride, 5 mL Total Volume in a… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | ketamine HCl, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL Total Volume in… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for… | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters | Leiter's Compounding | Terminated |
| Class II | October 19, 2016 | fentaNYL Citrate, 25 mcg per mL in 0.9% Sodium chloride, 1 mL Total Volume in a syringe,… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | lidocaine HCl, 2%, Preservative Free, Total Volume 2mL, Product code 2R3323, NDC… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL, 5mL Total Volume in a… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | fentaNYL Citrate, 5 mcg per mL, 0.9% Sodium Chloride, Preservative Free, 1 mL Total… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection (Injection) 1 mL Total Volume… | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters | Leiter's Compounding | Terminated |
| Class II | October 19, 2016 | lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 1 mL in a… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | atropine Sulfate Injection, 0.4 mg per mL, 0.8 mg per 2 mL, 2 mL Total Volume in a… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | HEPARIN Sodium Inj. USP, 15,000 USP Heparin Units per 3 mL Injection 3 mL Total Volume in… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | Vancomycin 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial… | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters | Leiter's Compounding | Terminated |
| Class II | October 19, 2016 | lidocaine HCl 1%, 10 mg per mL (50 mg per 5 mL), Preservative Free, 5 mL Total Volume in… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class I | October 19, 2016 | fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total… | Subpotent Drug: confirmed subpotency in one lot of this product that was packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class III | October 19, 2016 | mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose… | Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout… | Teva Pharmaceuticals USA | Terminated |
| Class II | October 19, 2016 | ePHEDrine Sulfate, 10 mg per mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preservative… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | succinylcholine Chloride Injection, 20 mg per mL, 100 mg per 5 mL, 5 mL Total Volume in a… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | PHENYLephrine HCl, 100 mcg per mL, 0.5 mg per 5 mL, in 0.9% Sodium Chloride, Preservative… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | fentaNYL Citrate, 10 mcg per mL (25 mcg per 2.5 mL), in 0.9% Sodium Chloride, 2.5 mL… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class I | October 19, 2016 | 5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun Medical… | Non-Sterility: fungal contamination due to leaking containers. | B. Braun Medical Inc | Terminated |
| Class II | October 19, 2016 | neostigmine Methylsulfate, 1 mg per mL, 3 mg per 3 mL, 3 mL Total Volume in a syringe,… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | Buffered Lidocaine, 2%, In Sodium Bicarbonate 8.4%, 3 mL Total Volume in a syringe, Local… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | methadone HCl, 2.5 mg per 0.5 mL, in 0.9% Sodium Chloride, 0.5 mL Total Volume in a… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | remifentanil HCl, 50 mcg per mL, 100 mcg per 2 mL, in 0.9% Sodium Chloride, Preservative… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal Injection, 1 mL… | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters | Leiter's Compounding | Terminated |
| Class II | October 19, 2016 | fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 mL Total… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | glycopyrrolate, 0.2 mg per mL, 0.4 mg per 2 mL, 2 mL Total Volume in a syringe, For IV… | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class II | October 19, 2016 | methadone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For… | Stability Data Does Not Support Expiry:potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC | Terminated |
| Class III | October 19, 2016 | ZENATANE ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only,… | Failed Dissolution Specifications | Dr. Reddy's Laboratories, Inc. | Terminated |
| Class II | October 19, 2016 | TAZORAC (tazarotene) Gel 0.05%, Rx only, For Dermatologic Use Only, Not for Ophthalmic… | Failed Content Uniformity Specifications | Allergan Sales, LLC | Terminated |
| Class II | October 19, 2016 | Marcaine Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL… | Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing… | Hospira Inc., A Pfizer Company | Terminated |
| Class II | October 19, 2016 | Marcaine Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL… | Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing… | Hospira Inc., A Pfizer Company | Terminated |
| Class III | October 12, 2016 | Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Blister Packs… | Failed Impurities/Degradation Specifications. | Teva North America | Terminated |
| Class II | October 12, 2016 | Methylcobalamin 5000 mcg/mL Injection, packaged in 1, 2, 3, 4, and 5 mL vials, IM, Rx,… | Lack of Assurance of Sterility; medication was sterilized with a recalled filter | The Apothecary Shoppe LLC | Terminated |
| Class II | October 12, 2016 | Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged in… | Lack of Assurance of Sterility; medication was sterilized with a recalled filter | The Apothecary Shoppe LLC | Terminated |
| Class II | October 12, 2016 | Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials, IM, Rx, The… | Lack of Assurance of Sterility; medication was sterilized with a recalled filter | The Apothecary Shoppe LLC | Terminated |
| Class III | October 12, 2016 | bupropion hydrochloride buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60… | Failed Dissolution Specifications | Sun Pharmaceutical Industries, Inc. | Terminated |
| Class II | October 12, 2016 | Prednisone PredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-Ward… | Failed Tablet/Capsule Specifications: Discovery of an underweight tablet. | West-Ward Pharmaceutical | Terminated |
| Class III | October 12, 2016 | Vyvanse Vyvanse (lisdexamfetamine dimesylate) Capsules 30 mg, 100 count bottle, Rx Only,… | Presence of Foreign Tablets/Capsules | Shire | Terminated |
| Class III | October 12, 2016 | Varithena Varithena (polidocanol injectable foam) Administration Pack For Use With Varithena, Rx… | Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack | Biocompatibles U.K., Ltd. | Terminated |
| Class II | October 5, 2016 | Brilliant Blue G (BBG) 0.025%, 0.5 ml SDV, Rx, Vital Care Compounder, Hattiesburg, MS… | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder | Terminated |
| Class II | October 5, 2016 | Pre-Op Pledget Soln, Ophthalmic Drops (Tropicamide (1%) 0.33ml, Phenylephrine (10%)… | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder | Terminated |
| Class II | October 5, 2016 | MOXI/DEX/KETOROLAC 0.5%/0.1%/0.4%, #15, Vital Care Compounder, Hattiesburg, MS 39402 | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder | Terminated |
| Class II | October 5, 2016 | Hyaluronidase, 150 u/ml, 10 ml SDV, Vital Care Compounder, Hattiesburg, MS 39402 | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder | Terminated |
| Class III | October 5, 2016 | Lansoprazole Delayed-Release Capsules, USP, 30 mg, packaged in 100-count cartons of 10 x… | Labeling: Label mix-up. The inner packaging was properly labeled Omeprazole DR 40mg Capsules, but the outer secondary… | Mckesson Packaging Services | Terminated |
| Class II | October 5, 2016 | Olopatadine 0.8% Ophthalmic Solution, 3ml bottle, Rx, Vital Care Compounder, Hattiesburg,… | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder | Terminated |
| Class II | October 5, 2016 | Hydroxyzine HCl, 50mg/ml Inj, 10ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder | Terminated |
| Class II | October 5, 2016 | Buprenorphine, 0.6 mg/ml Injection, 20ml MDV Sterile, Rx, Vital Care Compounder,… | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder | Terminated |
| Class II | October 5, 2016 | Pre-Op Pledget Soln + Tetracaine, (Tropicamide (1%) 0.47ml, Phenylephrine (10%) 0.93ml,… | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder | Terminated |
| Class II | October 5, 2016 | Apomorphine HCl 3mg/ml Sterile Injection Solution, 10 mL, MDV, Rx, Vital Care Compounder,… | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder | Terminated |
| Class II | October 5, 2016 | Morphine Sulfate 15mg/ml Injection, 20 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder | Terminated |
| Class II | October 5, 2016 | Autologous Serum Tears, 2 vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402 | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder | Terminated |
| Class II | October 5, 2016 | Chlorpheniramine Maleate 10 mg/ml, 30 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS… | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder | Terminated |
| Class II | October 5, 2016 | Papaverine 150 mg/Phentolamine 5 mg and Prostaglandin 50 mcg, packaged as 5.5 mL in a 10… | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder | Terminated |
| Class II | October 5, 2016 | Methylcobalamin 5,000mcg/ml, 1mL SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402 | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder | Terminated |
| Class II | October 5, 2016 | C-PAP/PHEN/PROST/Atrop 150/7.5 (Papaverine 150mg/Phentolamine 7.5mg/Prostaglandin… | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder | Terminated |
| Class II | October 5, 2016 | Moxifloxacin 0.5% + Dexamethazone 0.1%, 15ml vial Contains: Moxifloxacin 5mg/ml,… | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder | Terminated |
| Class II | October 5, 2016 | Moxifloxacin HCl 1 mg/ml (0.1mg/0.1ml) and BSS solution, 2ml Single use vial, Rx, Vital… | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder | Terminated |
| Class II | October 5, 2016 | C-PAP/PHEN/PROST/ATROP 150/5/5 (Papaverine 150mg/Phentolamine 5mg/Prostaglandin… | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder | Terminated |
| Class II | October 5, 2016 | Trypan Blue 0.3%, 0.5ml vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402 | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder | Terminated |
| Class II | October 5, 2016 | Papaverine 150 mg / Phentolamine 5 mg vials, packaged 5.5 mL in a sterile, clear 10 mL… | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder | Terminated |
| Class III | October 5, 2016 | Xanax (Alprazolam) USP, CIV, 0.5 mg tablets , 10 x 10 blister cards per carton, Rx Only,… | Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no product information (e.g.… | Mckesson Packaging Services | Terminated |
| Class II | October 5, 2016 | DMSO 50% with Lidocaine 0.5%, 50ml SDV, Sterile, Rx, Vital Care Compounder, Hattiesburg,… | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder | Terminated |
| Class II | October 5, 2016 | Sennazon (sennosides) Syrup, 8.8 mg, 8 fl. oz. (237 mL) bottle, Mfd. for: Bayshore… | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the… | Pharmatech LLC | Terminated |
| Class II | October 5, 2016 | Ninjacof-A (acetaminophen, chlophedianol HCl, pyrilamine maleate) Liquid, 160 mg/12.5… | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the… | Pharmatech LLC | Terminated |
| Class II | October 5, 2016 | Diocto Syrup (docusate sodium), 60 mg/15 mL, One Pint (473 mL) bottle, Dist. by: Rugby… | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the… | Pharmatech LLC | Terminated |
| Class II | October 5, 2016 | Senexon Liquid (sennosides) 8.8 mg, 8 fl oz. (237 mL) bottle, Distributed by: Rugby… | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the… | Pharmatech LLC | Terminated |
| Class II | October 5, 2016 | Senna Syrup (sennosides) 8.8 mg, 8 fl. oz. (237 mL) bottle, Distributed by: Major… | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the… | Pharmatech LLC | Terminated |
| Class II | October 5, 2016 | Aller-Chlor (chlorpheniramine maleate) Syrup, USP, 2 mg in each 5 mL, 4 fl oz (120 mL)… | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the… | Pharmatech LLC | Terminated |
| Class II | October 5, 2016 | Ninjacof (chlophedianol HCl and pyrilamine maleate) Liquid, 12.5 mg/12.5 mg in each 5 mL,… | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the… | Pharmatech LLC | Terminated |
| Class III | October 5, 2016 | Premarin PREMARIN (conjugated estrogen tablets, USP) 1.25 mg, 1000- count bottle, Rx only,… | Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11/17; the… | Pfizer Inc. | Terminated |
| Class III | October 5, 2016 | Lamotrigine Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by:… | Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets. | Unichem Pharmaceuticals Usa Inc | Terminated |
| Class II | September 28, 2016 | Papaverine 30 mg / Phentolamine 1 mg / mL -- 5 mL GLASS VIAL, Rx only, THE APOTHECARY, A… | Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate,… | W & C dba The Apothecary | Terminated |
| Class II | September 28, 2016 | Papaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin 25 mcg -- 4.2 mL GLASS VIAL, Rx… | Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate,… | W & C dba The Apothecary | Terminated |
| Class III | September 28, 2016 | Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ… | Labeling: Label Error on Declared Strength; label on outer carton incorrectly states Diphenhydramine 25 mg instead of… | Reckitt Benckiser LLC | Terminated |
| Class II | September 28, 2016 | Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 mL (NDC… | Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product… | Sandoz Inc | Terminated |
| Class II | September 28, 2016 | Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01),… | Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product… | Sandoz Inc | Terminated |
| Class III | September 28, 2016 | Carvediol Tablets, USP, 25 mg, 100-count bottle (NDC 57664-247-88), 500-count bottle (NDC… | Failed Impurities/Degradation Specifications | Sun Pharmaceutical Industries, Inc. | Terminated |
| Class II | September 28, 2016 | Calcium Gluconate 2.5% -- 20 mL PLASTIC SYRINGE, Rx only, THE APOTHECARY, A COMPOUNDING… | Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate,… | W & C dba The Apothecary | Terminated |
| Class II | September 28, 2016 | Calcium Gluconate 1% -- 1000 mL VIAFLEX IV BAG, Rx only, THE APOTHECARY, A COMPOUNDING… | Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate,… | W & C dba The Apothecary | Terminated |
| Class III | September 28, 2016 | Carvediol Tablets , USP, 3.125 mg, 100-count bottle (NDC 57664-242-88). 500-count bottle… | Failed Impurities/Degradation Specifications | Sun Pharmaceutical Industries, Inc. | Terminated |
| Class III | September 28, 2016 | Carvediol Tablets, USP, 12.5 mg, 500-count bottle (NDC 57664-245-13), 1000-count bottle… | Failed Impurities/Degradation Specifications | Sun Pharmaceutical Industries, Inc. | Terminated |
| Class II | September 28, 2016 | Prostaglandin 200 mcg/ 0.1 mL -- 25 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING… | Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate,… | W & C dba The Apothecary | Terminated |
| Class III | September 28, 2016 | Carvediol Tablets, USP, 6.25 mg, 100-count bottle (NDC 57664-244-18), 500-count bottle… | Failed Impurities/Degradation Specifications | Sun Pharmaceutical Industries, Inc. | Terminated |
| Class III | September 28, 2016 | Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when… | Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is… | West-Ward Pharmaceuticals Corp. | Terminated |
| Class III | September 28, 2016 | Escitalopram Escitalopram Tablets USP 20 mg, 100-count bottles, Rx Only, Manufactured for: Lupin… | Labeling: Incorrect or Missing Lot and/or Expiration Date | Lupin Limited | Terminated |
| Class III | September 28, 2016 | Lisinopril Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for: Lupin… | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed… | Lupin Pharmaceuticals Inc. | Terminated |
| Class III | September 28, 2016 | Mozobil (plerixafor injection) 24 mg/1.2 mL (20 mg/mL) per vial, Rx Only, For… | Labeling: Incorrect or Missing Lot and/or Exp. Date | Genzyme Corporation / Genzyme Biosurgery | Terminated |
| Class III | September 28, 2016 | Lisinopril Lisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-516-02) and b)… | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed… | Lupin Pharmaceuticals Inc. | Terminated |
| Class III | September 21, 2016 | buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx… | Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month… | Amerisource Health Services | Terminated |
| Class II | September 21, 2016 | Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets per bottle,… | Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of one foreign tablet… | Aurobindo Pharma USA Inc | Terminated |
| Class II | September 21, 2016 | DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be Diluted… | Discoloration: Firm received complaints of product discoloration and particulates. | Hospira Inc. | Terminated |
| Class II | September 14, 2016 | Bromocriptine mesylate Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by:… | Failed impurities/degradation specifications: Out of specification results noticed in related substance test during… | Zydus Pharmaceuticals USA Inc | Terminated |
| Class II | September 14, 2016 | Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA… | CGMP Deviations | Teva North America | Terminated |
| Class II | September 14, 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine… | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Amerisource Health Services | Terminated |
| Class III | September 14, 2016 | Selegiline HCL Tablets USP 5mg, 60- count bottles, Rx only, Manufactured by: Stason… | Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out of specification… | Stason Pharmaceuticals, Inc. | Terminated |
| Class II | September 14, 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine… | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Amerisource Health Services | Terminated |
| Class II | September 14, 2016 | Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intravenous Use… | CGMP Deviations | Teva North America | Terminated |
| Class II | September 14, 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine… | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Amerisource Health Services | Terminated |
| Class II | September 14, 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine… | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Amerisource Health Services | Terminated |
| Class II | September 14, 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine… | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Amerisource Health Services | Terminated |
| Class II | September 14, 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine… | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Amerisource Health Services | Terminated |
| Class II | September 14, 2016 | Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) 1 mL fill in… | Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was… | Allergy Laboratories, Inc. | Terminated |
| Class II | September 14, 2016 | Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection, 10 mL multidose vial,… | Lack of Processing Controls: Isomeric Pharmacy Solution, LLC announces a voluntary field action for the… | Isomeric Pharmacy Solution, LLC | Terminated |
| Class II | September 14, 2016 | Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for… | CGMP Deviations | Teva North America | Terminated |
| Class II | September 14, 2016 | ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only,… | CGMP Deviations | Teva North America | Terminated |
| Class II | September 14, 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine… | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Amerisource Health Services | Terminated |
| Class II | September 14, 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine… | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Amerisource Health Services | Terminated |
| Class II | September 14, 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine… | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Amerisource Health Services | Terminated |
| Class II | September 14, 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine… | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Amerisource Health Services | Terminated |
| Class III | September 14, 2016 | Amlodipine Besylate Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for:… | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed… | Lupin Limited | Terminated |
| Class III | September 14, 2016 | Amlodipine Besylate Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for:… | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed… | Lupin Limited | Terminated |
| Class III | September 7, 2016 | CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml… | Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for… | Clinique International | Terminated |
| Class III | September 7, 2016 | CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml… | Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for… | Clinique International | Terminated |
| Class III | September 7, 2016 | CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml… | Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for… | Clinique International | Terminated |
| Class III | September 7, 2016 | CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml… | Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for… | Clinique International | Terminated |
| Class III | September 7, 2016 | CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml… | Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for… | Clinique International | Terminated |
| Class III | September 7, 2016 | CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml… | Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for… | Clinique International | Terminated |
| Class II | August 31, 2016 | Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose… | CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to… | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Terminated |
| Class III | August 31, 2016 | Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by:… | Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month… | Akorn, Inc. | Terminated |
| Class III | August 31, 2016 | Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed by… | Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained… | Actavis Inc | Terminated |
| Class III | August 31, 2016 | Urea (50% Urea in a Cream Base), a) Net Wt. 5 oz (142 g), (NDC 42808-0200-05) b) Net Wt.… | Crystallization; complaints received by the manufacturer of crystals forming in product | Exact-Rx Inc | Terminated |
| Class III | August 31, 2016 | Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle,… | Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained… | Actavis Inc | Terminated |
| Class II | August 31, 2016 | Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) unit dose… | CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to… | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Terminated |
| Class II | August 31, 2016 | Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) unit dose… | CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to… | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Terminated |
| Class II | August 31, 2016 | Human Chorionic Gonadotropin Injection (a) 2500 iu, (b) 2500 iu with B12, (c) 3500 iu,… | Lack of Assurance of Sterility | Talon Compounding Pharmacy | Terminated |
| Class II | August 31, 2016 | Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection, 12 mg, 10 ml depyrogenated vials,… | Lack of Assurance of Sterility | Talon Compounding Pharmacy | Terminated |
| Class III | August 31, 2016 | Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz (142 g) and b) 9.0 oz (255 g) tubes,… | Crystallization; Complaints that cream appears to have crystallized | Stratus Pharmaceuticals Inc | Completed |
| Class II | August 31, 2016 | Amoxicillin Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In… | Superpotent drug: Out of specification test result for assay during stability testing. | Teva North America | Terminated |
| Class II | August 24, 2016 | Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By:… | Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour… | Actavis Inc | Terminated |
| Class II | August 24, 2016 | Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, 90 capsules per bottle, Rx… | Failed Dissolution Specifications: Out-of-specification results in retained sample. | Golden State Medical Supply Inc. | Terminated |
| Class II | August 24, 2016 | Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, a) 30 capsules per bottle,… | Failed Dissolution Specifications: Out-of-specification results in retained sample. | Golden State Medical Supply Inc. | Terminated |
| Class II | August 24, 2016 | Venlafaxine Hydrochloride Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC… | Failed Dissolution Specifications: out of specification dissolution results in retained samples | Zydus Pharmaceuticals USA Inc | Terminated |
| Class II | August 24, 2016 | Venlafaxine Hydrochloride Venlafaxine HCL ER Capsule USP, 75mg, packaged in a) 30-count bottles (NDC 68382-035-06),… | Failed Dissolution Specifications: out of specification dissolution results in retained samples | Zydus Pharmaceuticals USA Inc | Terminated |
| Class II | August 17, 2016 | Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in Canada by… | Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown… | Teva North America | Terminated |
| Class II | August 17, 2016 | Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical MFG, CORP.,… | Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits. | Spectrum Laboratory Products, Inc. | Terminated |
| Class III | August 10, 2016 | Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg per spray, 60… | Failed Content Uniformity Specifications: out of specification test result for spray content uniformity. | Teva North America | Terminated |
| Class II | August 10, 2016 | Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension, 7 mg/ mL,10… | Lack of processing controls: Isomeric Pharmacy Solution, LLC is recalling Betamethasone Acetate / Betamethasone Sodium… | Isomeric Pharmacy Solution, LLC | Terminated |
| Class II | August 10, 2016 | Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution,… | Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not… | Let's Talk Health, Inc. | Terminated |
| Class II | August 3, 2016 | dextroamphetamine sulfate Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only… | Failed Dissolution Specifications | Actavis Inc | Terminated |
| Class II | August 3, 2016 | Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - For IV Use,… | Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified… | Sagent Pharmaceuticals Inc | Terminated |
| Class III | August 3, 2016 | Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles,… | Failed Tablet/Capsule Specifications | Teva North America | Terminated |
| Class II | August 3, 2016 | Acetylcyst 10% OPHT SOL, 10%, 15 mL bottle, Rx only, Medicap Pharmacy, 2790 W Cherry… | Lack of Assurance of Sterility: Sterile products were not produced in a controlled, sterile environment. | Medicap Pharmacy | Terminated |
| Class III | August 3, 2016 | mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial… | Failed Impurities/Degradation Specifications: High out of specification results for Impurity D. | Teva North America | Terminated |
| Class II | July 27, 2016 | 0.5 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 10 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 2 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 5 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 2 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 1 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 0.5% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 2.5 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 0.4 mcg/mL Sufentanil Citrate and 0.0625% Bupivacaine HCl (Preservative Free), 150 mL in… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; , Service Code 2H8120… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | Bactroban Cream, (Mupirocin Calcium Cream 2%), 30 gram tube, Rx only, GlaxoSmithKline,… | Penicillin Cross Contamination | GlaxoSmithKline, LLC | Terminated |
| Class II | July 27, 2016 | 10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9%… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 10 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 1 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 400 mL in 500 mL Baxter… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 20 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, Service Code 2K8195,… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 0.1 mg/mL Morphine Sulfate and 0.05% Bupivacaine HCI (Preservative Free) in 0.9%, 150 mL… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 3 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 3 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 5 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 2.5 mcg/mL Fentanyl Citrate and 0.0312% Bupivacaine HCl (Preservative Free) in 0.9%… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 1 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 2 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 20 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 20 mcg/mL HYDROmorphone HCl and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 0.03% Bupivacaine HCl (Preservative Free) in Sodium Chloride 0.9%, 250 mL Medical… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 2 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 10 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 4 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 2 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 2 mcg/mL Fentanyl Citrate and 0.162% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 5 mcg/mL Fentanyl Citrate and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl in 0.9% Sodium Chloride, 250 mL… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | Bactroban Ointment, (Mupirocin Ointment 2%), 22 gram tube, Rx only, GlaxoSmithKline,… | Penicillin Cross Contamination | GlaxoSmithKline, LLC | Terminated |
| Class II | July 27, 2016 | Bactroban Nasal, (Mupirocin Calcium Ointment 2%), 1 gram Single Use Tubes, Rx only,… | Penicillin Cross Contamination | GlaxoSmithKline, LLC | Terminated |
| Class II | July 27, 2016 | 2 mcg/mL Fentanyl Citrate and 0.167% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 10 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 2 mcg/mL Fentanyl Citrate and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 3 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 0.4 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 8 mcg/mL HYDROmorphone HCl and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 1.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 2.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 5 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 6.66 mcg/mL Fentanyl Citrate and 0.22% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 5 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 10 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 3.5 mcg/mL Fentanyl Citrate and 0.0625%Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 1 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 2 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 2 mcg/mL Fentanyl Citrate and 0.083% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 2.5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 10 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 6.66 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9%… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 10 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 0.05 mg/mL Morphine Sulfate and 0.0625% Bupivacaine HCI (Preservative Free) in 0.9%… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 3 mcg/mL Fentanyl Citrate and 0.01% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 5 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 2 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 4 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 10 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 5 mcg/mL Fentanyl Citrate and 0.04% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 20 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 16.67 mcg/mL Fentanyl Citrate and 0.1667% Bupivacaine HCl (Preservative Free), 1.5 mL in… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, a) 250 mL Hospira… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 2.5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9%… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class II | July 27, 2016 | 20 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium… | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC | Terminated |
| Class III | July 27, 2016 | bupropion hydrochloride buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets… | Failed Dissolution Specifications | Sun Pharmaceutical Industries, Inc. | Terminated |
| Class II | July 27, 2016 | Bactroban Cream, (Mupirocin Calcium Cream 2%), 15 gram tube, Rx only, GlaxoSmithKline,… | Penicillin Cross Contamination | GlaxoSmithKline, LLC | Terminated |
| Class II | July 20, 2016 | B-COMPLEX 50 IN NACL 0.9% (PF) B1-50MG, B2-5-PO4-5MG, B3-50MG, B5-50MG, B6-50MG/ML, 2ML… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | B-COMPLEX WITHOUT B12 W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG,… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Te Xiao BaiNeiTing Herbal Supplement (Naphazoline HCl Solution 0.1%) liquid, Net Wt.… | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease… | Murray International Trading Co., Inc. | Terminated |
| Class II | July 20, 2016 | Cefazolin 3GM Added to a 100 mL 0.9% Sodium Chloride Bag, Rx Only, Compounded by… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Hydromorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Adenosine 1mg/ml (PF) in 0.9% Sodium Chloride (Total 90 mg/90 ml in 100 mL PAB… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |