Gilchew IR FDA Alerts
The FDA Alerts below may be specifically about Gilchew IR or relate to a group or class of drugs which include Gilchew IR.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.
Recent FDA Alerts for Gilchew IR
Edge Pharma, LLC Issues Voluntary Nationwide Recall of All Drug Products Due to Lack of Sterility Assurance
December 4, 2021 – Colchester, VT, Edge Pharma, LLC is voluntarily recalling all lots of all drugs compounded at Edge Pharma, LLC to the consumer level. All products are being recalled due to process issues that could lead to a lack of sterility assurance for products intended to be sterile and could impact the safety and quality of non-sterile products.
Risk Statement: Administration of a drug product intended to be sterile, that is not sterile, could result in site specific infections as well as serious systemic infections which may be life- threatening. To date, Edge Pharma, LLC has not received and is not aware of any adverse events related to this recall.
The products are used for a variety of indications and are packaged in Containers, IV bags, Syringes, Drop containers, Vials, Bottles, and Jars. The affected lots and expiration dates are included in the link listed below. The names and concentration of the drugs are listed in the table following this release.
LINK TO LOT NUMBERS, DISTRIBUTION DATES & DRUG INFORMATION WILL BE ACTIVE ON 12-08-21.
The recall encompasses all compounded sterile and nonsterile drug products, within expiry, that were dispensed from Edge Pharma, LLC. The products subject to this recall were distributed nationwide and directly to customers and/or medical facilities. The products can be identified by the label containing the Edge Pharma, LLC name and logo.
Edge Pharma, LLC is notifying its customers by email, Media and FDA alerts, and direct outreach. Consumers and institutions that have Edge Pharma, LLC products should stop using the products immediately and may either return or discard the recalled lots.
Consumers with questions regarding this recall can contact Edge Pharma, LLC by phone number or e-mail address on Monday-Friday from 8:00 am to 4:00 pm, EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
| STERILE PRODUCTS | NDC |
|---|---|
| ALUMINUM POTASSIUM SULFATE CONCENTRATED (PF) 300 G/300 ML | 05446-0637-03 |
| BUFFERED LIDOCAINE HCL (PF) 1% | 05446-0850-10 |
| BUFFERED LIDOCAINE HCL / EPINEPHRINE SOLUTION (PF) 1% / 1:100,000 | 05446-1268-01 |
| CEFTAZIDIME (PF) 22.5 MG/ML | 05446-0733-01 |
| CEFUROXIME OPHTHALMIC SOLUTION (PF) 10 MG/ML | 05446-1003-01 |
| DEXAMETHASONE PHOSPHATE (PF) 24 MG/ML | 05446-0848-01 |
| EDETATE DISODIUM (EDTA) (PF) 1.5% | 05446-1427-10 |
| EDETATE DISODIUM (EDTA) (PF) 3% | 05446-1428-10 |
| EPINEPHRINE / LIDOCAINE HCL (PF) 0.025% / 0.75% | 05446-0863-01 |
| GEMCITABINE (PF) 20 MG/ML | 05446-1566-50 |
| GLYCERIN, STERILE (PF) 99% | 05446-1486-03 |
| LIDOCAINE HCL / BUPIVACAINE HCL / HYALURONIDASE (PF) 2% / 0.375% / 15 UNITS/ML | 05446-1548-18 |
| METHACHOLINE CHALLENGE 5 SYRINGE TEST KIT | 05446-1600-05 |
| METHACHOLINE CHLORIDE (PF) 16 MG/ML | 05446-1241-01 |
| METHACHOLINE CHLORIDE (PF) 4 MG/ML | 05446-1246-01 |
| METHACHOLINE CHLORIDE (PF) 1 MG/ML | 05446-1247-01 |
| METHACHOLINE CHLORIDE (PF) 0.25 MG/ML | 05446-1248-01 |
| METHACHOLINE CHLORIDE (PF) 0.0625 MG/ML | 05446-1249-01 |
| METHOTREXATE (PF) 125 MG/5ML | 05446-1505-05 |
| MITOMYCIN IRRIGATION (PF) 1 MG/ML | 05446-1416-01 |
| MITOMYCIN-C (PF) 0.4 MG/ML | 05446-1009-01 |
| MITOMYCIN-C (PF) 0.2 MG/ML | 05446-1011-01 |
| MOXIFLOXACIN HCL (PF) 1 MG/ML | 05446-1050-01 |
| MVASI 3.75MG/0.15ML (25 MG/ML) | 05446-1661-13 |
| NEOSTIGMINE METHYLSULFATE 1 MG/ML | 05446-1549-05 |
| NOREPINEPHRINE BITARTRATE 8 MG/250ML | 05446-1179-03 |
| PHENOL, STERILE (PF) 6% | 05446-1476-05 |
| PHENYLEPHRINE / TROPICAMIDE / KETOROLAC / CIPROFLOXACIN (PF) 10% / 1% / 0.125% / 0.3% | 05446-1270-01 |
| PHENYLEPHRINE HCL 0.1 MG/ML | 05446-1544-10 |
| PHENYLEPHRINE HCL 0.1 MG/ML | 05446-1545-05 |
| PHENYLEPHRINE HCL (PF) 800 MCG/10 ML | 05446-1652-01 |
| PHENYLEPHRINE HCL (PF) 20 MG/ 250 ML | 05446-1667-01 |
| PHENYLEPHRINE HCL / LIDOCAINE HCL (PF) 1.5% / 1% | 05446-1118-01 |
| PHENYLEPHRINE HCL / TROPICAMIDE 2.5% / 1% | 05446-0815-01 |
| PHENYLEPHRINE/ CYCLOPENTOLATE / TROPICAMIDE / KETOROLAC 10% / 0.25% / 0.25% / 0.125% | 05446-0859-03 |
| PHENYLEPHRINE/ CYCLOPENTOLATE / TROPICAMIDE / KETOROLAC (PF) 2.5% / 0.25% / 0.25% / 0.125% | 05446-0993-01 |
| POVIDONE-IODINE (PF) 5% | 05446-1680-01 |
| TRYPAN BLUE (PF) 0.03% | 05446-1200-01 |
| VANCOMYCIN HCL (PF) 10 MG/ML | 05446-0736-01 |
| VANCOMYCIN HCL (PF) 1250 MG/250ML | 05446-1456-01 |
| VANCOMYCIN HCL (PF) 1500 MG/512ML | 05446-1458-01 |
| VANCOMYCIN HCL (PF) 1750 MG/514ML | 05446-1459-01 |
| STERILE PRODUCTS | NDC |
|---|---|
| PRESCRIPTION ALLERGY TREATMENT SETS DISTRIBUTED BETWEEN 12-02-20 to 12-01-21 | N/A |
| NON-STERILE PRODUCTS | NDC |
|---|---|
| BENZOCAINE / LIDOCAINE / TETRACAINE 20% / 8% / 4% | 05446-1235-01 |
| CANTHARIDIN 0.7% | 05446-0572-03 |
| CANTHARIDIN PLUS 1% / 30% | 05446-0970-03 |
| CIPROFLOXACIN / SULFACETAMIDE SODIUM / AMPHOTERICIN B 30MG / 50MG / 5MG | 05446-1633-01 |
| CIPROFLOXACIN / SULFACETAMIDE SODIUM / AMPHOTERICIN B / HYDROCORTISONE 30MG / 50MG / 5MG / 25MG |
05446-1634-01 |
| DEXAMETHASONE IONTOPHORESIS 0.4% | 05446-0622-01 |
| DIBUTYL SQUARATE 2% | 05446-1047-03 |
| DIBUTYL SQUARATE 1% | 05446-1156-03 |
| LIDOCAINE / TETRACAINE 23% / 7% | 05446-1647-01 |
| LIDOCAINE HCL / EPINEPHRINE / TETRACAINE HCL (LET) 4%/0.05%/0.5% | 05446-0607-01 |
| LIDOCAINE HCL / OXYMETAZOLINE 4% / 0.05% | 05446-1256-01 |
| LIDOCAINE HCL / PRILOCAINE HCL / TETRACAINE HCL (PROFOUND) DENTAL (RASPBERRY MARSHMALLOW) 10% / 10% / 4% |
05446-0790-10 |
| LIDOCAINE HCL / PRILOCAINE HCL / TETRACAINE HCL (PROFOUND) DENTAL GEL (MINT) 10% / 10% / 4% |
05446-0407-10 |
| LIDOCAINE HCL / PRILOCAINE HCL / TETRACAINE HCL / PHENYLEPHRINE HCL (PROFOUND-PE) DENTAL (RASPBERRY MARSHMALLOW) 10% / 10% / 4% / 2% |
05446-1018-10 |
| LIDOCAINE HCL / PRILOCAINE HCL / TETRACAINE HCL / PHENYLEPHRINE HCL (PROFOUND-PE) DENTAL GEL (MINT) 10% / 10% / 4% / 2% |
05446-0408-10 |
| PHENOL 89% | 05446-1211-03 |
| PHENYLEPHRINE HCL / LIDOCAINE HCL 1% / 4% | 05446-1045-03 |
| PHYTONADIONE (VITAMIN K) 5 MG/ML | 05446-1132-03 |
| PROMETHAZINE HCL 25 MG / 1.2ML | 05446-1341-01 |
| TETRACAINE HCL 4% | 05446-1195-03 |
| VANCOMYCIN HCL 125 MG / 2.5ML (50 MG/ML) | 05446-1348-01 |
Source: FDA
Sagent Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Phenylephrine Hydrochloride Injection, USP, 10 mg/mL Due to Potential Lack of Sterility Assurance
March 11, 2021 -- Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of three lots of Phenylephrine Hydrochloride Injection, USP (10 mg/mL). This product was manufactured by Indoco Remedies Ltd. and distributed by Sagent Pharmaceuticals, Inc. Sagent has initiated this voluntary recall of Phenylephrine Hydrochloride Injection, USP to the user level as the result of a customer complaint due to potentially loose crimped vial overseals. A non-integral crimped vial overseal may result in a non-sterile product.
Intravenous administration of a product intended to be sterile that is not sterile could result in serious systemic infections which may be life-threatening. The possibility of a breach in sterility assurance in distributed product, while remote, cannot be eliminated. To date, Sagent has not received reports of any adverse events associated with this issue.
Phenylephrine Hydrochloride Injection, USP is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important low blood pressure resulting primarily from the dilation of blood vessels, which decreases blood pressure in the setting of anesthesia.
The product is supplied in 3 mL glass tubular vials. The lot numbers being recalled were distributed to hospitals, wholesalers and distributors nationwide in the USA from 11/17/2020 – 03/08/2021.
| Product | Lot Number | Expiration Date | NDC Number | Distribution Dates |
|---|---|---|---|---|
| Phenylephrine Hydrochloride Injection, USP | PHT8IB2 PHT9IB2 PHT1JB2 | 08/2022 08/2022 09/2022 | 25021-315-01 | November 17, 2020 – March 8, 2021 |
Customers are being notified by fax, email, FedEx, and/or certified mail that includes arrangements for return of all recalled product. Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return the recalled lots listed above. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. Consumers/distributors/retailers that have product which is being recalled should stop using product and return the recalled product. The necessary form by which to document this information as well as other information regarding this recall is available at www.Sagentpharma.com.
Customers or consumers with any questions about returning unused product should be directed to the customer call center at (866) 625-1618 M-F, 8am-7pm CST. Healthcare workers who have medical questions about Phenylephrine Hydrochloride Injection, USP, may contact Medical Affairs (866-625-1618, Option 3) M-F, 8am-5pm CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Source: FDA
Injectable Products by SCA Pharmaceuticals: Recall - Potential Contamination
ISSUE: SCA Pharmaceuticals LLC (“SCA Pharmaceuticals”) is voluntarily recalling various lots of injectable products to the hospital level. There is a potential for the products to contain microbial contamination. See the recall notice for a full list of products.
BACKGROUND: Administration of a drug product, intended to be sterile, that may contain microbial contamination has the potential to result in serious adverse events which may include life-threatening infections. SCA Pharmaceuticals has not received any customer complaints or reports of adverse events related to this issue.
RECOMMENDATION: SCA Pharmaceuticals is notifying its customers via telephone, email and US mail and is arranging for return/replacement of all recalled products. Customers that have product which is being recalled, as indicated in the list above, should discontinue use immediately and return the product to SCA Pharmaceuticals.
Consumers with questions regarding this recall can contact SCA Pharmaceuticals at 877-550-5059, between the hours of 8:00 am and 5:00 pm (Central Standard Time), Monday thru Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
[10/20/2017 - Recall Notice - SCA Pharmaceuticals]
