FDC Pharma are recalling batch 087B087 due to an out of specification result for an unknown impurity during stability testing. (EL(18)A/08)
MDR number
MDR 076-04/18
Company name
FDC Pharma
Product description
Latanoprost / Timolol 50 micrograms/mL + 5mg/mL
Eye Drops, Solution
PL 35638/0004
Batch number/expiry
| Batch Number | Expiry Date | Pack Size | First Distribution |
| 087B087 | 01/2019 | 1 x 2.5 mL | 15/06/2017 |
Brief description of the problem
FDC Pharma are recalling the above batch due to an out of specification result for an unknown impurity during stability testing.
Advice for healthcare professionals
Stop dispensing the batch listed above. Quarantine and return all remaining stock of this batch to your supplier using the supplier’s approved process.
Advice for wholesalers and distributors
Refer to the instructions provided by FDC Pharma. Stop distributing the batch listed above. Quarantine and return all remaining stock of this batch to your supplier using the supplier’s approved process.