Why it was recalled
Lack of Assurance of Sterility
Product description
B-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HCl 2%, Niacinamide 2%, Thiamine HCl 2%, Chlorobutanol 0.5%, Riboflavin 0.05%, Chromic Chloride 0.003%), 30 mL Multi-Dose Vial, packaged in 2 x 30 mL Multi-Dose Vials per carton, US Specialty Formulations, LLC, 116 Research Drive, Bethlehem, PA 18015, P/N: 234-15523
Lot numbers, UPCs & expiration codes
Lot #: 02RP1507A, exp. date 30-Jun-22; 02RP1512A, exp. date 30-Sep-22; 02RP1514A, exp. date 31-Nov-22; 02RP1515A, exp. date 31-Dec-22
Where it was sold
Product was distributed to medical facilities and a physician's office Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0987-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 24, 2022
- FDA report date
- Jun 15, 2022
- Quantity
- 1992 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- US Specialty Formulations LLC
Original FDA data
Every field from FDA enforcement report D-0987-2022, exactly as published.
Show all FDA fields
- City
- Allentown
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 90257
- Address
- 1401 S Albert St
- Code information
- Lot #: 02RP1507A, exp. date 30-Jun-22; 02RP1512A, exp. date 30-Sep-22; 02RP1514A, exp. date 31-Nov-22; 02RP1515A, exp. date 31-Dec-22
- Postal code
- 18103-4141
- Report date
- Jun 15, 2022
- Product type
- Drugs
- Recall number
- D-0987-2022
- Classification
- Class II
- Recalling firm
- US Specialty Formulations LLC
- Product quantity
- 1992 vials
- Termination date
- Jun 17, 2024
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- B-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HCl 2%, Niacinamide 2%, Thiamine HCl 2%, Chlorobutanol 0.5%, Riboflavin 0.05%, Chromic Chloride 0.003%), 30 mL Multi-Dose Vial, packaged in 2 x 30 mL Multi-Dose Vials per carton, US Specialty Formulations, LLC, 116 Research Drive, Bethlehem, PA 18015, P/N: 234-15523
- Distribution pattern
- Product was distributed to medical facilities and a physician's office Nationwide in the USA.
- Recall initiation date
- May 24, 2022
- Initial firm notification
- Letter
- Center classification date
- Jun 6, 2022