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.
Download document