Products Affected - Description

• • 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

• • 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
  • Lentocilin intramuscular powder for solution for injection, Mark Cuban Cost Plus Drug Company (MCCPDC), 1,200,000 units, 1,200,000 unit vial of powder/4 mL 1.5% lidocaine for injection in ampules vial, 1 count, NDC 84383-0110-01
  • Extencilline intramuscular powder for solution for injection, Provepharm, 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, Provepharm, 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 1 mL syringes on back order and the company estimates a release date of February 2025.

• • CDC has a Clinical Reminder regarding how to evaluate supply and recommendations for use of other products such as doxycycline when possible. 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/sti/php/from-the-director/2023-07-20-mena-bicillin.html

• • 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 Laboratories 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.
  • FDA is allowing temporary importation of Lentocilin (benzathine benzylpenicillin tetrahydrate) in units of 1,200,000 units powder for injection vials with 4 mL of 1.5% lidocaine as diluent. This non-FDA approved product is marketed in Portugal and manufactured by Laboratories Atral S.A. in Portugal. The barcode may not register on US systems. The product is being distributed by Mark Cuban Cost Plus Drug Company (MCCPDC) via TopRx at [email protected] or 1-800-542-8677.
  • The main differences between Lentocilin and Bicillin-LA include that Lentocilin is only available by prescription in the US, but does not have the common statement "Rx only". Instead it says "medicinal product subject to medical prescription". Lentocilin comes as a powder and diluent of 1.5% lidocaine for reconstitution while Bicillin-LA is a prefilled syringe. More details can be found at: https://www.fda.gov/media/179787/download?attachment.