Summary: Check your Bicillin LA and save remaining supply to treat pregnant people and infants with syphilis.
Pfizer voluntarily recalled 12 lots of Benzathine Penicillin G Injectable Suspension (Bicillin LA) after particulates were found during a visual inspection.
The recall comes amid high syphilis diagnoses across the U.S. Penicillin is the only recommended treatment for pregnant people and infants with congenital syphilis.
We recommend that you:
- Check if your supply is affected by the recall and follow the guidance if it is.
- Reserve most of your remaining supply for pregnant people with syphilis and infants with congenital syphilis.
- Use doxycycline to treat syphilis in anyone who cannot become pregnant if you believe they can follow the treatment regimen.
Background
King Pharmaceuticals LLC., a subsidiary of Pfizer, voluntarily recalled 12 lots of Benzathine Penicillin G Injectable Suspension (Bicillin LA). The recall came after particulates were identified during visual inspection.
Pfizer completed a Health Hazard Assessment, which indicated the potential risk to patients is medium. Pfizer has reported it is not aware of any adverse events and there is no indication of reduced efficacy or need for retreatment.
You can find a list of affected lots at the end of this advisory.
Pfizer is still working to determine the impact of the recall on its production timeline. For the time being, the Centers for Disease Control and Prevention (CDC) said it expects a limited supply of Bicillin LA.
The recall comes amid high syphilis diagnoses across the U.S. In particular, the number of infants born with syphilis continues to rise at an alarming rate.
Actions requested
Penicillin is the only recommended treatment for pregnant people with syphilis and infants with congenital syphilis. After you check to see if you have any of the affected lots, you should prioritize most of your remaining supply for pregnant people with syphilis and infants with congenital syphilis.
Additionally:
- Perform a pregnancy test on anyone you diagnose with syphilis who is capable of becoming pregnant.
- Test all pregnant people for syphilis 3 times during pregnancy.
- At first prenatal care visit, at 24–28 weeks gestation, and at delivery.
- All pregnant people and infants diagnosed with syphilis should receive benzathine penicillin.
- Treat pregnant people prophylactically if they were exposed to syphilis, regardless of disease classification.
- If your patient is capable of becoming pregnant, treat them with benzathine penicillin if you have an adequate supply.
- Use doxycycline to treat syphilis in patients who cannot get pregnant if you believe they can complete the treatment regimens detailed below.
- Depending on your supply of benzathine penicillin, consider using doxycycline for people who are capable of becoming pregnant but are not currently pregnant.
Alternate treatment regimens using doxycycline (not to be used for pregnant people or infants)
- Treat early syphilis—primary, secondary, and early non-primary non-secondary syphilis—with doxycycline 100mg twice a day for 14 days.
- Patients are classified as having early syphilis if they meet any of the following criteria:
- Signs or symptoms of primary or secondary syphilis with a positive syphilis serology.
- A new syphilis diagnosis based on positive syphilis serologies (positive treponemal test and RPR) in someone with negative syphilis serologies in the prior year.
- A sustained (>2 weeks) 4-fold increase in RPR titer compared to a titer obtained the prior year.
- A new serologic diagnosis of syphilis in a person with an unequivocal history of symptoms or primary or secondary syphilis in the prior year or a sex partner with a diagnosis of primary, secondary or early non-primary non-secondary syphilis.
- Patients are classified as having early syphilis if they meet any of the following criteria:
- Treat late latent syphilis or syphilis of unknown duration with doxycycline 100 mg twice a day for 28 days. Classify patients as having late latent syphilis or syphilis of unknown duration if they:
- Are asymptomatic.
- Have a new positive syphilis serologic test (treponemal test and RPR) or a sustained 4-fold increase in RPR.
- Do not meet the criteria for early syphilis defined above.
Treatment approach for people who might face challenges completing treatment
- For people eligible for treatment with doxycycline who might face challenges with adherence to treatment, select a treatment approach based on your supply of benzathine penicillin and your assessment of individual needs.
- People with early syphilis who might face challenges with completing a 14-day course of doxycycline can be treated with a single dose of benzathine penicillin if you have sufficient supply.
- People with late latent syphilis or unknown duration syphilis who might face challenges with adherence can be treated with:
- 3 weekly doses of benzathine penicillin if you have sufficient supply and you believe they can complete the 3 injections.
- A single 2.4 million unit intramuscular dose of benzathine penicillin AND a 28 days course of doxycycline 100mg twice a day.
- Doxycycline 100 mg twice a day for 28 days if you believe they can complete this regimen.
Need more info or have questions?
Questions?- For urgent issues, call (253) 649-1412.
- For non-urgent issues, call (253) 649-1413 and leave a message.
- Includes reporting notifiable conditions 24 hours a day, 7 days a week.
- Leave the patient’s name, date of birth and disease.
Recalled Pfizer benzathine penicillin
| Carton NDC | Syringe NDC | Lot Number | Expiration Date YYMMDD | Strength | Configuration/ Count |
| 60793-701-10 | 60793-701-02 | GL2954 HP6222 HP6228 HP6232 HR9967 HJ3235 LT5190 | 270131 270131 271031 270930 270531 260930 270930 | 1,200,000 units/ 2 mL | 10 (2 mL) syringes per carton, 24 cartons per shipping case |
| 60793-702-10 | 60793-702-04 | GT2598 GT2599 HR9969 HK2909 HR9984 | 260930 260930 270430 270228 270831 | 2,400,000 units/ 4 mL | 10 (4 mL) syringes per carton, 24 cartons per shipping case |