| Apr 12, 2019 |
Norepinephrine 16 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Gol... |
Lack of sterility assurance. |
Class II |
CMC Enterprise Pharmacy |
| Apr 12, 2019 |
NICARdipine 25 mg in NS 250 mL EXCEL bag, Made by: Enterprise Pharmacy, 4400 ... |
Lack of sterility assurance. |
Class II |
CMC Enterprise Pharmacy |
| Apr 12, 2019 |
CefTRIAXone 1 GM, 100 mg/mL, 10 mL syringe, Made by: Enterprise Pharmacy, 440... |
Lack of sterility assurance. |
Class II |
CMC Enterprise Pharmacy |
| Apr 12, 2019 |
Phenylephrine 0.8 mg/10 mL NS (0.08 mg/mL), (80 mcg/mL) syringe, Made by: Ent... |
Lack of sterility assurance. |
Class II |
CMC Enterprise Pharmacy |
| Apr 12, 2019 |
Labetalol 20 mg/4 mL, 20 mg in 4 mL syringe, Made by: Enterprise Pharmacy, 44... |
Lack of sterility assurance. |
Class II |
CMC Enterprise Pharmacy |
| Apr 12, 2019 |
Alteplase 1 mg/mL 1 mL in 10 mL syringe, Made by: Enterprise Pharmacy, 4400 G... |
Lack of sterility assurance. |
Class II |
CMC Enterprise Pharmacy |
| Apr 12, 2019 |
Magnesium Sulfate 4 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Go... |
Lack of sterility assurance. |
Class II |
CMC Enterprise Pharmacy |
| Apr 12, 2019 |
Lidocaine Buffered with J-Tip 0.25 mL, 1 mL syringe, 10:1, For Intradermal Us... |
Lack of sterility assurance. |
Class II |
CMC Enterprise Pharmacy |
| Apr 12, 2019 |
Clindamycin 900 mg in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf A... |
Lack of sterility assurance. |
Class II |
CMC Enterprise Pharmacy |
| Apr 12, 2019 |
Vancomycin 2000 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Ph... |
Lack of sterility assurance. |
Class II |
CMC Enterprise Pharmacy |
| Apr 12, 2019 |
Vancomycin 1250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf ... |
Lack of sterility assurance. |
Class II |
CMC Enterprise Pharmacy |
| Apr 12, 2019 |
Magnesium Sulfate 6 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Go... |
Lack of sterility assurance. |
Class II |
CMC Enterprise Pharmacy |
| Apr 12, 2019 |
Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bag, 160 mcg/mL, Made by: ... |
Lack of sterility assurance. |
Class II |
CMC Enterprise Pharmacy |
| Apr 12, 2019 |
Sodium Bicarbonate 150 mEq in D5W 1000 mL bags, Made by: Enterprise Pharmacy,... |
Lack of sterility assurance. |
Class II |
CMC Enterprise Pharmacy |
| Apr 12, 2019 |
Heparin Pork 30,000 Units in NS 1000 mL bag, Made by: Enterprise Pharmacy, 44... |
Lack of sterility assurance. |
Class II |
CMC Enterprise Pharmacy |
| Apr 12, 2019 |
Oxytocin 30 units in NS 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf A... |
Lack of sterility assurance. |
Class II |
CMC Enterprise Pharmacy |
| Apr 12, 2019 |
Lidocaine 1% - Sodium Bicarb 8.4% 10:1, 10 mL syringe, For Intradermal Use On... |
Lack of sterility assurance. |
Class II |
CMC Enterprise Pharmacy |
| Apr 12, 2019 |
Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1, 1 mL syringe, For Intradermal Use... |
Lack of sterility assurance. |
Class II |
CMC Enterprise Pharmacy |
| Apr 12, 2019 |
DelNido Cardioplegia (Normosol-R pH 7.4 or Plasma-Lyte A pH 7.4 1000 mL bag) ... |
Lack of sterility assurance. |
Class II |
CMC Enterprise Pharmacy |
| Apr 12, 2019 |
CeFAZolin 3 gm 100 mg/mL, 30 mL syringe, Made by: Enterprise Pharmacy, 4400 G... |
Lack of sterility assurance. |
Class II |
CMC Enterprise Pharmacy |
| Apr 12, 2019 |
Magnesium Sulfate 2 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Go... |
Lack of sterility assurance. |
Class II |
CMC Enterprise Pharmacy |
| Apr 12, 2019 |
Dexmedetomidine 400 mcg in NS 100 mL bag, Made by: Enterprise Pharmacy, 4400 ... |
Lack of sterility assurance. |
Class II |
CMC Enterprise Pharmacy |
| Apr 12, 2019 |
CeFAZolin 2 GM a) in NS 100 mL bag; b) 100 mg/mL (20 mL) syringe, Made by: En... |
Lack of sterility assurance. |
Class II |
CMC Enterprise Pharmacy |
| Apr 12, 2019 |
Chlorothiazide 100 mg, 3.57 mL syringe, Made by: Enterprise Pharmacy, 4400 Go... |
Lack of sterility assurance. |
Class II |
CMC Enterprise Pharmacy |
| Feb 22, 2019 |
Golean DETOX capsules, 14 Net: 56 g, 14 packets containing 2 capsules per pac... |
Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain undeclared sibutrami... |
Class I |
Golean Detox US |
| Oct 26, 2018 |
deb stoko, Refresh AntiBac FOAM (benzalkonium chloride), 0.13%, 1 L (33.8 fl.... |
CGMP Deviations: Product was released to market prior to microbiological testing. |
Class II |
S.C. Johnson Professional |
| Oct 26, 2018 |
Alcohol Free Foaming Hand Sanitizer (benzalkonium chloride), 0.13%, 1 L (33.8... |
CGMP Deviations: Product was released to market prior to microbiological testing. |
Class II |
S.C. Johnson Professional |
| Aug 21, 2018 |
Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufact... |
Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets US... |
Class I |
Accord Healthcare, Inc. |
| Aug 21, 2018 |
Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx ... |
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary cont... |
Class III |
Mayne Pharma Inc |
| Aug 14, 2018 |
Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) I... |
Defective Delivery System: Water ingress through the lower water cup sensor of the device. |
Class III |
United Therapeutics Corp. |
| Jul 20, 2018 |
Dr. King's SafeCare Rx LymePlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westsid... |
Microbial contamination |
Class I |
King Bio Inc. |
| Jul 20, 2018 |
Dr. King's SafeCare Rx CS-Lymph Hodgkins, 2 fl. oz. (59 mL), King Bio, Inc., ... |
Microbial contamination |
Class I |
King Bio Inc. |
| Jul 20, 2018 |
Dr. King's SafeCare Rx Smoke Control, 2 fl. oz. (59 mL), King Bio, Inc., 3 We... |
Microbial contamination |
Class I |
King Bio Inc. |
| Jul 20, 2018 |
Dr. King's SafeCare Rx Gout Symptom Relief, 2 fl. oz. (59 mL), King Bio, Inc.... |
Microbial contamination |
Class I |
King Bio Inc. |
| Jul 20, 2018 |
Dr. King's Natural Medicine Homeopathic Climate Adaptation Cold & Damp, 2 fl.... |
Microbial contamination |
Class I |
King Bio Inc. |
| Jul 20, 2018 |
Dr. King's Natural Medicine Homeopathic Heavy Metal Detox, 2 fl. oz. (59 mL),... |
Microbial contamination |
Class I |
King Bio Inc. |
| Jul 20, 2018 |
Dr. King's SafeCare Rx No Sweat/Anti-Perspirant, 2 fl. oz. (59 mL), King Bio,... |
Microbial contamination |
Class I |
King Bio Inc. |
| Jul 20, 2018 |
Dr. King's SafeCare Rx Children's Cough Children High Potency Homeopathic For... |
Microbial contamination |
Class I |
King Bio Inc. |
| Jul 20, 2018 |
Dr. King's SafeCare Rx PMS Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 West... |
Microbial contamination |
Class I |
King Bio Inc. |
| Jul 20, 2018 |
Dr. King's SafeCare Rx Total Body Detox Cleansing & Detox, 2 fl. oz. (59 mL),... |
Microbial contamination |
Class I |
King Bio Inc. |
| Jul 20, 2018 |
Dr. King's Natural Medicine Homeopathic Urinary Tract Irritations, 2 fl. oz. ... |
Microbial contamination |
Class I |
King Bio Inc. |
| Jul 20, 2018 |
People's Best Arnica Gel Homeopathic Medicine Pain Relief, Net Wt. 2.6 oz (73... |
Microbial contamination |
Class I |
King Bio Inc. |
| Jul 20, 2018 |
Dr. King's SafeCare Rx Gossipy, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside... |
Microbial contamination |
Class I |
King Bio Inc. |
| Jul 20, 2018 |
Dr. King's SafeCare Rx Sugar Metabolizer Men/Women, 2 fl. oz. (59 mL), King B... |
Microbial contamination |
Class I |
King Bio Inc. |
| Jul 20, 2018 |
NET Remedies #11 (Lilac Label) Homeopathic Preparation, Oral Liquid, 57 mL, M... |
Microbial contamination |
Class I |
King Bio Inc. |
| Jul 20, 2018 |
NET Remedies #12 Homeopathic Preparation, Oral Liquid, 57 mL, Manufacturer: K... |
Microbial contamination |
Class I |
King Bio Inc. |
| Jul 20, 2018 |
Dr. King's Natural Medicine Homeopathic Eye Stress, 2 fl. oz. (59 mL), King B... |
Microbial contamination |
Class I |
King Bio Inc. |
| Jul 20, 2018 |
Dr. King's Natural Medicine Homeopathic Arthritis Pain & Joint Relief, 2 fl. ... |
Microbial contamination |
Class I |
King Bio Inc. |
| Jul 20, 2018 |
Dr. King's Natural Medicine Homeopathic Constipation Relief, 2 fl. oz. (59 mL... |
Microbial contamination |
Class I |
King Bio Inc. |
| Jul 20, 2018 |
Dr. King's SafeCare Rx ApoPlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside... |
Microbial contamination |
Class I |
King Bio Inc. |