Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Medicine |
| Medsafe Reference: | 23758 |
| Brand Name: | Caffeine Citrate Injection 20 mg/mL |
| Dose Form/Strength: | |
| Affected: | |
| Recalling Organisation: | |
| Contact Information: | |
| Manufacturer: | |
| Issue: | Caffeine Citrate Injection 20 mg/mL manufactured at Biomed potentially contaminated with stearic and palmic acid polymers. Contamination is due from the API raw material. This product is used for two neonatal medicines to treat sleep apnea: - 2.5 mL ampoule which is diluted with saline and administered by IV (filtered). This is manufacturing using hot water, which Biomed would consider solubilizes the contaminants. - Oral product, filtered using a 5 micron filter. There is a risk that sterile product for injection contains this contaminant, which may cause harm to the patient. |
| Recall action type: | Recall |
| Recall action: | Recall |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 3/1/2019 |
