FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Bupivacaine Hydrochloride Injection, USP
Status: Currently in Shortage
»Date first posted: No date available
»Therapeutic Categories: Anesthesia

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AuroMedics Pharma LLC (mfd. by Aurobindo Pharma Ltd.) (Revised 06/07/2018)

Company Contact Information:
888-238-7880

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.25% 10 mL Single Dose Vials (NDC 55150-167-10) Limited supply, intermittent backorders expected Additional quantities expected by late July Demand increase for the drug
0.25% 30 mL Single Dose Vials (NDC 55150-168-30) Limited supply, intermittent backorders expected Additional quantities expected by late August Demand increase for the drug
0.5% 10 mL Single Dose Vials (NDC 55150-169-10) Limited supply, intermittent backorders expected Additional quantities expected by mid-June Demand increase for the drug
0.5% 30 mL Single Dose Vials (NDC 55150-170-30) Limited supply, intermittent backorders expected Additional quantities expected by mid-June Demand increase for the drug
0.75% 10 mL Single Dose Vials (NDC 55150-171-10) Currently available, intermittent backorders expected Next shipment TBD Demand increase for the drug
0.75% 30 mL Single Dose Vials (NDC 55150-172-30) Limited supply, intermittent backorders expected Additional quantities expected by early September Demand increase for the drug
0.25% 50 mL Multiple Dose Vials (NDC 55150-249-50) Currently backordered Additional quantities expected by mid-June Demand increase for the drug
0.5% 50 mL Multiple Dose Vials (NDC 55150-250-50) Currently backordered Additional quantities expected by early September Demand increase for the drug

Fresenius Kabi USA, LLC (Revised 06/26/2018)

Company Contact Information:
888-386-1300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Sensorcaine 0.25% (125 mg per 50 mL) (2.5 mg per mL) MDV (NDC 63323-465-57) Backordered. Next release anticipated July 2018. All Bupivacaine presentations are on intermittent back order and will be released as the product becomes available. Product will ship into the wholesalers. Demand increase for the drug
Sensorcaine 0.5% (250 mg per 50 mL) (5 mg per mL) MDV (NDC 63323-467-57) Backordered. Next release anticipated July 2018. Demand increase for the drug
Sensorcaine 0.25% (25 mg per 10 mL) (2.5 mg per mL) MPF, SDV (NDC 63323-464-17) Backordered. Next release anticipated July 2018. Check wholesalers for inventory. Demand increase for the drug
Sensorcaine MPF 0.25% (75 mg per 30 mL) (2.5 mg per mL) MPF, SDV (NDC 63323-464-37) Backordered. Next release anticipated July 2018. Check wholesalers for inventory. Demand increase for the drug
Sensorcaine 0.25% (75 mg per 30 mL) (2.5 mg per mL) MPF, Sterile-Pak, SDV (NDC 63323-464-31) Backordered. Next release date not available at this time. Check wholesalers for inventory. Demand increase for the drug
Sensorcaine 0.5% (50 mg per 10 mL) (5 mg per mL) MPF, SDV (NDC 63323-466-17) Backordered. Next release anticipated July 2018. Check wholesalers for inventory. Demand increase for the drug
Sensorcaine 0.5% (150 mg per 30 mL) (5 mg per mL) MPF, SDV (NDC 63323-466-37) Backordered. Next release anticipated July 2018. Check wholesalers for inventory. Demand increase for the drug
Sensorcaine 0.5% (150 mg per 30 mL) (5 mg per mL) MPF, Sterile-Pak, SDV (NDC 63323-466-31) Backordered. Next release date not available at this time. Demand increase for the drug
Sensorcaine 0.75% (75 mg per 10 mL) (7.5 mg per mL) MPF, SDV (NDC 63323-472-17) Backordered. Next release date not available at this time. Demand increase for the drug
Sensorcaine 0.75% (225 mg per 30 mL) (7.5 mg per mL) MPF, SDV (NDC 63323-472-37) Backordered. Next release date not available at this time. Check wholesalers for inventory. Demand increase for the drug

Hospira, Inc. (Revised 07/20/2018)

Company Contact Information:
844-646-4398

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
25 mg/10 mL (2.5 mg/mL); Single Dose Glass Teartop Vial (NDC 00409-1159-01) Next Delivery: September 2018; Estimated Recovery: 2019 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay Other
75 mg/30 mL (2.5 mg/mL); Single Dose Glass Teartop Vial (NDC 00409-1159-02) Next Delivery: November 2018; Estimated Recovery: 2019 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay Other
125 mg/50 mL (2.5 mg/mL); Multiple Dose Glass Fliptop Vial (NDC 00409-1160-01) Next Delivery: July 2018; Estimated Recovery: September 2018 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay Other
50 mg/10 mL (5 mg/mL); Single Dose Glass Teartop Vial (NDC 00409-1162-01) Next Delivery and Estimated Recovery: 2019 Shortage per Manufacturer: Manufacturing Delay Other
150 mg/30 mL (5 mg/mL); Single Dose Glass Teartop Vial (NDC 00409-1162-02) Next Delivery: August 2018; Estimated Recovery: 2019 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay Other
250 mg/50 mL (5 mg/mL); Multiple Dose Glass Fliptop Vial (NDC 00409-1163-01) Next Delivery: August 2018; Estimated Recovery: December 2018 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay Other
75 mg/10 mL (7.5 mg/mL); Single Dose Glass Teartop Vial (NDC 00409-1165-01) Next Delivery: September 2018; Estimated Recovery: December 2018 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay Other
225 mg/30 mL (7.5 mg/mL); Single Dose Glass Teartop Vial (NDC 00409-1165-02) Next Delivery: November 2018; Estimated Recovery: December 2018 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay Other
Bupivacaine Spinal 15 mg/2 mL (7.5 mg/mL); Glass Ampul (NDC 00409-3613-01) Next Delivery: September 2018; Estimated Recovery: October 2018 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
Marcaine 25 mg/10 mL (2.5 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-1559-10) Next Delivery and Estimated Recovery: 2019 Shortage per Manufacturer: Manufacturing Delay Other
Marcaine 75 mg/30 mL (2.5 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-1559-30) Next Delivery and Estimated Recovery: 2019 Shortage per Manufacturer: Manufacturing Delay Other
Marcaine 125 mg/50 mL (2.5 mg/mL); Multiple Dose Glass Fliptop Vial (NDC 00409-1587-50) Next Delivery and Estimated Recovery: 2019 Shortage per Manufacturer: Manufacturing Delay Other
Marcaine 50 mg/10 mL (5 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-1560-10) Next Delivery and Estimated Recovery: 2019 Shortage per Manufacturer: Manufacturing Delay Other
Marcaine 150 mg/30 mL (5 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-1560-29) Next Delivery and Estimated Recovery: 2019 Shortage per Manufacturer: Manufacturing Delay Other
Marcaine 250 mg/50 mL (5 mg/mL); Multiple Dose Glass Fliptop Vial (NDC 00409-1610-50) Next Delivery and Estimated Recovery: 2019 Shortage per Manufacturer: Manufacturing Delay Other
Marcaine 75 mg/10 mL (7.5 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-1582-10) Next Delivery and Estimated Recovery: 2019 Shortage per Manufacturer: Manufacturing Delay Other
Marcaine 225 mg/30 mL (7.5 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-1582-29) Next Delivery and Estimated Recovery: 2019 Shortage per Manufacturer: Manufacturing Delay Other
Marcaine Spinal 15 mg/2 mL (7.5 mg/mL); Glass Ampul (NDC 00409- 1761-02) Next Delivery: August 2018; Estimated Recovery: September 2018 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other

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