AuroMedics Pharma LLC
AuroMedics Pharma LLC lists 13 drug products in the FDA National Drug Code directory.
Products
| NDC | Product | Strength | Type |
|---|---|---|---|
| 55150-155 | Acyclovir Sodium Injection, Solution | Acyclovir Sodium 1000 mg/20mL | Rx |
| 55150-180 | Amiodarone Hydrochloride Injection, Solution | Amiodarone Hydrochloride 150 mg/3mL | Rx |
| 55150-181 | Amiodarone Hydrochloride Injection, Solution | Amiodarone Hydrochloride 450 mg/9mL | Rx |
| 55150-182 | Amiodarone Hydrochloride Injection, Solution | Amiodarone Hydrochloride 900 mg/18mL | Rx |
| 55150-216 | Atracurium Besylate Injection, Solution | Atracurium Besylate 50 mg/5mL | Rx |
| 55150-217 | Atracurium Besylate Injection, Solution | Atracurium Besylate 100 mg/10mL | Rx |
| 55150-364 | Cyanocobalamin Injection, Solution | Cyanocobalamin 1000 ug/mL | Rx |
| 55150-292 | Glycopyrrolate Injection, Solution | Glycopyrrolate .2 mg/mL | Rx |
| 55150-293 | Glycopyrrolate Injection, Solution | Glycopyrrolate .2 mg/mL | Rx |
| 55150-294 | Glycopyrrolate Injection, Solution | Glycopyrrolate .2 mg/mL | Rx |
| 55150-295 | Glycopyrrolate Injection, Solution | Glycopyrrolate .2 mg/mL | Rx |
| 55150-320 | Sodium Nitroprusside Injection | Sodium Nitroprusside 50 mg/2mL | Rx |
| 55150-266 | Zoledronic Acid Injection, Solution, Concentrate | Zoledronic Acid 4 mg/5mL | Rx |
Recalls by AuroMedics Pharma LLC
- D-0020-2023 Nov 2, 2022 · Class II
Subpotent Drug: Out of specification for assay - D-0013-2023 Oct 26, 2022 · Class II
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial. - D-1551-2022 Oct 12, 2022 · Class III
Presence of Particulate Matter: Piece of metal found in a vial - D-0556-2022 Feb 16, 2022 · Class I
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot - D-0248-2021 Feb 10, 2021 · Class II
Discoloration and failed pH specifications - D-0853-2020 Feb 26, 2020 · Class III
Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples). - D-0852-2020 Feb 19, 2020 · Class II
Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie - D-0789-2020 Jan 22, 2020 · Class III
Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution. - D-0653-2020 Dec 25, 2019 · Class II
Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles.. - D-0637-2020 Dec 18, 2019 · Class I
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets. - D-0636-2020 Dec 18, 2019 · Class I
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets. - D-0574-2020 Dec 18, 2019 · Class II
Discoloration: Product complaints of discoloration after reconstitution of vials. - D-0609-2020 Dec 11, 2019 · Class II
Discoloration; Hazy solution found in one vial instead of a clear solution. - D-0573-2020 Dec 4, 2019 · Class II
Presence of Foreign Substance: Foreign material found inside the vial. - D-0530-2020 Dec 4, 2019 · Class II
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups. - D-0529-2020 Dec 4, 2019 · Class II
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups. - D-0528-2020 Dec 4, 2019 · Class II
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups. - D-0527-2020 Dec 4, 2019 · Class II
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups. - D-0526-2020 Dec 4, 2019 · Class II
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups. - D-0522-2020 Dec 4, 2019 · Class III
Crystallization: Presence of visible particulate matter.