Class 3 Medicines Recall: Sodium Cromoglicate eye drops and Murine Hayfever Relief eye drops (MDR 072-05/17)
FDC International Ltd are recalling specific batches of Sodium Cromoglicate 2% w/v Eye Drops 13.5ml and Murine Hayfever Relief 2% w/v Eye Drops 10ml due to the presence of a precipitate, which has been identified as Sodium Cromoglicate, in some bottles.
Product information
MDR number
MDR 072-05/17
Company name
FDC International Ltd
Product description
Sodium Cromoglicate 2% w/v Eye Drops 13.5ml
Eye Drops, Solution
PL 15872/0010
Murine Hayfever Relief 2% w/v 10ml Eye Drops (GSL)
Eye Drops, Solution
PL 15872/0008
Batch number/expiry
- Product: Sodium Cromoglicate 2% w/v Eye Drops 13.5ml
- Batch Number: 086I069
- Expiry Date: 08/2019
- First Distribution: 03/03/2017
- Product: Murine Hayfever Relief 2% w/v Eye Drops 10ml
- Batch Number: 086L075
- Expiry Date: 11/2018
- First Distribution: 11/05/2017
Brief description of the problem
FDC International Ltd is recalling the above batches due to the presence of a precipitate, which has been identified as Sodium Cromoglicate, in some bottles.
Advice for healthcare professionals and wholesalers
All remaining packs of the listed batches should be quarantined and returned to the original supplier.
Medical Information enquiries and stock enquiries
For medical and stock availability information enquiries please contact Santosh Amoncar: 01489 565 222; 07903 203039 or email [email protected].
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Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS Regional Teams are asked to forward this to community pharmacists, hospital pharmacists and dispensing general practitioners. It is not necessary to forward this notice to non-dispensing GPs.