Ativan 4mg/1ml Solution for injection CLASS 4 MEDICINES DEFECT INFORMATION

News By 24th April 2019

CLASS 4 MEDICINES DEFECT INFORMATION – Ativan 4mg/1ml Solution for injection

Dear Healthcare Professional, Pfizer Limited Ativan 4mg/1ml Solution for injection PL 00057/1279 (Lorazepam)

Batch Number Expiry Date Pack Size First Distributed

4091 Oct 2019 10 x 1ml 15 Apr 2019

4092 Dec 2019 10 x 1ml 10 Apr 2019

4094 Dec 2019 10 x 1ml NA

Pfizer Limited has informed us that the text on the carton label for the above product has recently been updated and at this time, the product description on the carton was changed from 10 x 1ml ampoules to 10 x 2ml ampoules. The updated text reflects the size of the ampoules, which is 2ml. The concentration and total volume of the ampoules has not changed and remains 4mg Lorazepam in 1ml of solution.
The size of the ampoules (2ml) has not changed and the label on the ampoules remains unchanged and states ‘4mg in 1ml’.

We understand that the carton label is in the process of being revised to reflect the volume of solution contained in the ampoules and batches with the revised labels are expected to become available during Q3 2019.
Further Information
For further information, please contact Pfizer Medical Information, tel: 01304 616161.   Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter.