Class 4 Medicines Defect Information: Ativan 4mg/1ml Solution for injection (MDR 57-04/19)
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.
Company name
Pfizer Limited
Product description
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 |
Brief description of the problem
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. NHS Regional Teams are asked to forward this to relevant clinics, community pharmacists and dispensing General Practitioners for information.
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter.
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