Specific batches of Omeprazole 20mg gastro-resistant capsules (hard) - capsule shells may be more brittle than normal

(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 UK-Medicalinformation@sanofi.com.

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.

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Specific batches of Omeprazole 20mg gastro-resistant capsules EL (15)A/13

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