FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Ropivacaine Hydrochloride injection
Status: Currently in Shortage
»Date first posted: 03/23/2018
»Therapeutic Categories: Anesthesia

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Akorn Pharmaceuticals (Revised 07/06/2018)

Company Contact Information:
800-932-5676

Presentation	Availability and Estimated Shortage Duration	Related Information	Shortage Reason (per FDASIA)
0.5% 5mg/mL, 30mL, 1 Vial (NDC 17478-0081-30)	Available		Other

AuroMedics Pharma LLC (mfd. by Aurobindo Pharma Ltd.) (Revised 08/20/2018)

Company Contact Information:
888-238-7880

Presentation	Availability and Estimated Shortage Duration	Related Information	Shortage Reason (per FDASIA)
0.2% 20 mL Single Dose Vials (NDC 55150-195-20)	Available		Demand increase for the drug
0.2% 100 mL Single Dose Infusion Bottles (NDC 55150-196-99)	Available		Demand increase for the drug
0.5% 20 mL Single Dose Vials (NDC 55150-197-20)	Available		Demand increase for the drug
0.5% 30 mL Single Dose Vials (NDC 55150-198-30)	Available		Demand increase for the drug
0.75% 20 mL Single Dose Vials (NDC 55150-199-20)	Available		Demand increase for the drug
1% 10 mL Single Dose Vials (NDC 55150-200-10)	Currently backordered	Next shipment expected late August	Demand increase for the drug
1% 20 mL Single Dose Vials (NDC 55150-201-20)	Currently available	Next shipment TBD	Demand increase for the drug

Fresenius Kabi USA, LLC (Revised 10/15/2018)

Company Contact Information:
888-386-1300

Presentation	Availability and Estimated Shortage Duration	Related Information	Shortage Reason (per FDASIA)
2 mg per mL / 0.2% (20 mg per 10 mL), Plastic Ampule, Sterile-Pak (NDC 63323-285-10)	Available	Check wholesaler for inventory	Manufacturing Delay
2 mg per mL / 0.2% (40 mg per 20 mL), Plastic Ampule, Sterile-Pak (NDC 63323-285-20)	Available	Check wholesaler for inventory	Manufacturing Delay
5 mg per mL / 0.5% (100 mg per 20 mL), Plastic Ampule, Sterile-Pak (NDC 63323-286-20)	Available	Check wholesaler for inventory	Manufacturing Delay
7.5 mg per mL / 0.75% (150 mg per 20 mL), Plastic Ampule, Sterile-Pak (NDC 63323-287-20)	Available	Check wholesaler for inventory	Manufacturing Delay
10 mg per mL / 1% (100 mg per 10 mL), Plastic Ampule, Sterile-Pak (63323-288-10)	Available	Check wholesaler for inventory	Manufacturing Delay
10 mg per mL / 1% (200 mg per 20 mL), Plastic Ampule, Sterile-Pak (NDC 63323-288-20)	Available	Check wholesaler for inventory	Manufacturing Delay
2 mg per mL / 0.2% (200 mg per 100 mL), Single Dose Free Flex Bag (NDC 63323-285-61)	Backordered. Next release November 2018.	Check wholesaler for inventory	Manufacturing Delay
2 mg per mL / 0.2% (400 mg per 200 mL), Single Dose Free Flex Bag (NDC 63323-285-63)	Available	Check wholesaler for inventory	Manufacturing Delay
2 mg per mL / 0.2% (200 mg per 100 mL), Single Dose Infusion Bottle (NDC 63323-285-65)	Available	Check wholesaler for inventory	Manufacturing Delay
2 mg per mL / 0.2% (400 mg per 200 mL), Single Dose Infusion Bottle (NDC 63323-285-64)	Available	Check wholesaler for inventory	Manufacturing Delay
5 mg per mL / 0.5% (500 mg per 100 mL), Single Dose Infusion Bottle (NDC 63323-286-00)	Backordered. Next release November 2018.	Check wholesaler for inventory	Manufacturing Delay
5 mg per mL / 0.5% (1,000 mg per 200 mL), Single Dose Infusion Bottle (NDC 63323-286-63)	Available	Check wholesaler for inventory	Manufacturing Delay
2 mg per mL / 0.2% (20 mg per 10 mL), Single Dose Vial (NDC 63323-285-13)	Available	Check wholesaler for inventory	Manufacturing Delay
2 mg per mL / 0.2% (40 mg per 20 mL), Single Dose Vial (NDC 63323-285-23)	Available	Check wholesaler for inventory	Manufacturing Delay
5 mg per mL / 0.5% (150 mg per 30 mL), Single Dose Vial (NDC 63323-286-35)	Available	Check wholesaler for inventory	Manufacturing Delay
5 mg per mL / 0.5% (100 mg per 20 mL), Single Dose Vial (NDC 63323-286-23)	Available	Check wholesaler for inventory	Manufacturing Delay
7.5 mg per mL / 0.75% (150 mg per 20 mL), Single Dose Vial (NDC 63323-287-21)	Available	Check wholesaler for inventory	Manufacturing Delay
10 mg per mL / 1% (100 mg per 10 mL), Single Dose Vial (NDC 63323-288-11)	Available	Check wholesaler for inventory	Manufacturing Delay
10 mg per mL / 1% (200 mg per 20 mL), Single Dose Vial (NDC 63323-288-21)	Available	Check wholesaler for inventory	Manufacturing Delay
5 mg per mL / 0.5% (150 mg per 30 mL), Sterile-Pack, Single Dose Vial (NDC 63323-286-31)	Backordered. Next release November 2018.		Manufacturing Delay

Hospira, Inc. (Reverified 10/11/2018)

Company Contact Information:
844-646-4398

Presentation	Availability and Estimated Shortage Duration	Shortage Reason (per FDASIA)
20 mg/10 mL (2 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-9300-10)	Available	Other
40 mg/20 mL (2 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-9300-20)	Available	Other
150 mg/30 mL (5 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-9301-30)	Available	Other
150 mg/20 mL (7.5 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-9302-20)	Available	Other
100 mg/10 mL (10 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-9303-10)	Available	Other
200 mg/20 mL (10 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-9303-20)	Available	Other