Products Affected - Description

• • Bicillin L-A intramuscular suspension for injection, Pfizer, 1,200,000 units, 2 mL syringe, 10 count, NDC 60793-0701-10
  • Bicillin L-A intramuscular suspension for injection, Pfizer, 2,400,000 units, 4 mL syringe, 10 count, NDC 60793-0702-10
  • Bicillin L-A intramuscular suspension for injection, Pfizer, 600,000 units, 1 mL syringe, 10 count, NDC 60793-0700-10

Reason for the Shortage

• • Pfizer has Bicillin-LA on shortage due to increased demand. Pfizer is allocating resources towards manufacturing adult Bicillin-LA presentations due to increased syphilis infection rates. Once current supplies of the pediatric Bicillin-LA vials are depleted it is unclear when more product will be manufactured. A Dear Healthcare Professional Letter can be found at: https://www.fda.gov/media/169427/download.
  • Pfizer is the sole supplier of penicillin G benzathine injection.

Available Products

• • Extencilline intramuscular powder for solution for injection, Pfizer, 1,200,000 units, 20 mL vial of powder/5 mL water for injection in ampules vial, 10 count, NDC 81284-0521-01
  • Extencilline intramuscular powder for solution for injection, Pfizer, 2,400,000 units, 20 mL vial of powder/5 mL water for injection in ampules vial, 10 count, NDC 81284-0522-01

• • Pfizer has Bicillin-LA 600,000 units/mL 2 mL and 4 mL syringes available in limited supply. The 1 mL syringes are on back order and the company estimates a release date of February 2025.

• • CDC has a Technical Assistance Note regarding tracking and forecasting penicillin G benzathine injection due to the intermittent shortages of the product. This document is aimed to help public health entities ensure they have supply of penicillin G benzathine for patients with syphilis. This note can be found at: https://www.cdc.gov/std/funding/docs/STD-PCHD-TA-Notes-11c-Benzathine-Penicillin-G.pdf

• • FDA is allowing temporary importation of Extencilline (benzathine benzylpenicilin) in units of 1,200,000 units and 2,400,000 units. This non-FDA approved product is marketed in France and manufactured by Delbert in Italy. The barcode may not register on US systems. The product is being distributed by Provepharm via Direct Success at [email protected] or 1-877-404-3338.
  • The main differences between Extencilline and Bicillin-LA are warnings that are not on the Extencilline labeling. Refer to the Bicillin-LA labeling. Extenciline contains soy phospholipids and may cause hypersensitivity reactions to patients with a history of allergy to soybeans. Extencilline comes as a powder for reconstitution while Bicillin-LA is a prefilled syringe. More details can be found at: https://www.fda.gov/media/175366/download.