| Mar 16, 2020 |
rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use... |
Firm is recalling 46 lots of various products because of a lack of sterility ... |
Class II |
| Mar 16, 2020 |
ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL... |
Firm is recalling 46 lots of various products because of a lack of sterility ... |
Class II |
| Mar 16, 2020 |
fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare B... |
Firm is recalling 46 lots of various products because of a lack of sterility ... |
Class II |
| Mar 16, 2020 |
nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP... |
Firm is recalling 46 lots of various products because of a lack of sterility ... |
Class II |
| Mar 16, 2020 |
rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, ... |
Firm is recalling 46 lots of various products because of a lack of sterility ... |
Class II |
| Mar 16, 2020 |
ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 ... |
Firm is recalling 46 lots of various products because of a lack of sterility ... |
Class II |
| Mar 16, 2020 |
fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe,... |
Firm is recalling 46 lots of various products because of a lack of sterility ... |
Class II |
| Mar 16, 2020 |
HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per... |
Firm is recalling 46 lots of various products because of a lack of sterility ... |
Class II |
| Mar 16, 2020 |
fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, Fo... |
Firm is recalling 46 lots of various products because of a lack of sterility ... |
Class II |
| Mar 16, 2020 |
fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,... |
Firm is recalling 46 lots of various products because of a lack of sterility ... |
Class II |
| Mar 16, 2020 |
ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride ... |
Firm is recalling 46 lots of various products because of a lack of sterility ... |
Class II |
| Mar 16, 2020 |
ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL B... |
Firm is recalling 46 lots of various products because of a lack of sterility ... |
Class II |
| Mar 16, 2020 |
succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, F... |
Firm is recalling 46 lots of various products because of a lack of sterility ... |
Class II |
| Dec 16, 2019 |
NORepinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP (16 ... |
Subpotent Drug |
Class III |
| Dec 16, 2019 |
NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 ... |
Subpotent Drug |
Class III |
| Dec 16, 2019 |
NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 ... |
Subpotent Drug |
Class III |
| Jun 7, 2019 |
Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syri... |
Incorrect Product Formulation; Firm's customer resource center (CRC) statemen... |
Class I |
| Dec 5, 2018 |
Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in... |
Sub-potent |
Class II |
| Dec 5, 2018 |
Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% i... |
Sub-potent |
Class II |
| Jul 24, 2018 |
10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL... |
CGMP deviations: Product was released while a hood certification discrepancy ... |
Class II |
| Jul 24, 2018 |
5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in... |
CGMP deviations: Product was released while a hood certification discrepancy ... |
Class II |
| Jul 24, 2018 |
10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium S... |
CGMP deviations: Product was released while a hood certification discrepancy ... |
Class II |
| Jun 5, 2018 |
HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in... |
Superpotent and Subpotent |
Class II |
| Apr 10, 2018 |
Vasopressin 50 Units added to 250 mL 0.9% Sodium Chloride Injection USP (0.2 ... |
cGMP deviations |
Class III |
| Feb 5, 2018 |
15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag... |
Lack of assurance of sterility: Three lots were released where there was a fa... |
Class II |
| Feb 5, 2018 |
100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe,... |
Lack of assurance of sterility: Three lots were released where there was a fa... |
Class II |
| Feb 5, 2018 |
0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 25... |
Lack of assurance of sterility: Three lots were released where there was a fa... |
Class II |
| Dec 27, 2017 |
Ropivacaine HCl Injection in all strengths, all doses, and all packaging. |
Lack of sterility assurance. |
Class II |
| Dec 27, 2017 |
Dexamethasone Sodium Phosphate in all strengths, all doses, and all packaging. |
Lack of sterility assurance. |
Class II |
| Dec 27, 2017 |
Fentanyl Citrate and Bupivacaine HCl in 0.9% Sodium Chloride in all strengths... |
Lack of sterility assurance. |
Class II |
| Dec 27, 2017 |
Nicardipine HCl in all strengths, all doses, and all packaging. |
Lack of sterility assurance. |
Class II |
| Dec 27, 2017 |
Midazolam HCl Injection in all strengths, all doses, and all packaging. |
Lack of sterility assurance. |
Class II |
| Dec 27, 2017 |
Methadone HCl Injection in all strengths, all doses, and all packaging. |
Lack of sterility assurance. |
Class II |
| Dec 27, 2017 |
Meperidine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all p... |
Lack of sterility assurance. |
Class II |
| Dec 27, 2017 |
Dexamethasone Sodium Phosphate added to 5% Dextrose in all strengths, all dos... |
Lack of sterility assurance. |
Class II |
| Dec 27, 2017 |
Lidocaine HCl in all strengths, all doses, and all packaging. |
Lack of sterility assurance. |
Class II |
| Dec 27, 2017 |
Neostigmine Methylsulfate Injection in all strengths, all doses, and all pack... |
Lack of sterility assurance. |
Class II |
| Dec 27, 2017 |
Esmolol HCl in all strengths, all doses, and all packaging. |
Lack of sterility assurance. |
Class II |
| Dec 27, 2017 |
Ketamine HCl Injection in all strengths, all doses, and all packaging. |
Lack of sterility assurance. |
Class II |
| Dec 27, 2017 |
Midazolam HCl in 0.9% Sodium Chloride in all strengths, all doses, and all pa... |
Lack of sterility assurance. |
Class II |
| Dec 27, 2017 |
Atropine Sulfate Injection in all strengths, all doses, and all packaging. |
Lack of sterility assurance. |
Class II |
| Dec 27, 2017 |
HYDROmorphone HCl Injection in all strengths, all doses, and all packaging. |
Lack of sterility assurance. |
Class II |
| Dec 27, 2017 |
Vecuronium Bromide in Sterile Water for Injection in all strengths, all doses... |
Lack of sterility assurance. |
Class II |
| Dec 27, 2017 |
HYDROmorphone HCl in 5% Dextrose in all strengths, all doses, and all packaging. |
Lack of sterility assurance. |
Class II |
| Dec 27, 2017 |
Phenylephrine HCl in 0.9% Sodium Chloride in all strengths, all doses, and al... |
Lack of sterility assurance. |
Class II |
| Dec 27, 2017 |
Lidocaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all pa... |
Lack of sterility assurance. |
Class II |
| Dec 27, 2017 |
Morphine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all... |
Lack of sterility assurance. |
Class II |
| Dec 27, 2017 |
Rocuronium Bromide in all strengths, all doses, and all packaging. |
Lack of sterility assurance. |
Class II |
| Dec 27, 2017 |
Ephedrine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and al... |
Lack of sterility assurance. |
Class II |
| Dec 27, 2017 |
Potassium Chloride in 0.9% Sodium Chloride in all strengths, all doses, and a... |
Lack of sterility assurance. |
Class II |