Omeprazole from Zentiva - Recall of batches

[helvella]

If you have this product, I suggest you follow the link and check up whether the batch you have is affected.

(Zentiva) Pharmacists should quarantine remaining stock and return to original wholesaler (EL (15)A/13)

16 December 2015

Class 3 medicines recall

Distribute to pharmacy

Action within 5 days

MDR 72-11/15

Product details

Zentiva

Omeprazole 20mg gastro-resistant capsules, hard

PL 17780/0524

Batch Number Expiry date Pack Size First distributed

5ZR2190D Mar 2017 1 x 28 7 Sep 2015

5ZR2191C Mar 2017 1 x 28 2 Oct 2015

5ZR2190E Apr 2017 1 x 28 8 Sep 2015

5ZR2512C Apr 2017 1 x 28 12 Oct 2015

Alert details

Zentiva is recalling the above batches of Omeprazole 20mg gastro-resistant capsules because the capsule shells are more brittle than normal. This may result in some capsules breaking as they are removed from blisters.

Pharmacists are asked to quarantine any remaining stock of the above batches and return them to the original wholesaler for credit.

For further information, including stock enquiries, contact Sanofi Medical Information department on 0845 3727101 or email [e-mail].

Recipients of this drug alert should bring it to the attention of relevant contacts by copy of this letter.

Local area teams are asked to forward this to relevant clinics, community pharmacists and dispensing general practitioners.

gov.uk/drug-device-alerts/s...

[Clutter]

Helvella, do you know whether pharmacies contact patients to recall their prescriptions?

[helvella Administrator Thyroid UK in reply to Clutter]

Not in the case of a Class 3 Pharmacy Level recall.

MHRA Drug Alert Classifications:

Class 1 – Immediate action (includes out of hours)

Class 2 – Action within 48 hours

Class 3 – Action within 5 days

Class 4 – Caution in use

I think Class 2 recalls are split with some requiring patient contact, others not.

Flabbergasts me that, with a 5-day horizon, pharmacists could carry on dishing this out for the best part of a week. Seemingly not being a problem.

And it is pretty poor that the recall notice doesn't explain the impact of the defect. If it is just a nuisance - OK. But perhaps Omeprazole shouldn't come into contact with the lining of the mouth and throat?

[amssmith7]

Thank you I am on a double dose at the moment I will check when I get home x

[Zephyrbear]

Thanks for posting this! My daughter takes these for an ulcer and she may not be aware of this recall...