Pfizer issues warning about Rifampin vials

TB drug might not meet potency standards and could be the wrong colour

Pfizer has issued a warning letter to wholesalers and healthcare professionals about some 600mg vials of Rifampin for Injection USP, a treatment for TB, that might not meet potency standards and could be the wrong colour following problems in the drug manufacturing process.

Pfizer said the effect of these changes to patients is not known, but any adverse reactions should be reported to the FDA’s MedWatch Adverse Event reporting programme.

The affected vials contain a brown/black powder rather than the expected red. This discoloration will also be apparent during the reconstitution process and in the final solution.

Pfizer said it is currently investigating this matter and advises health professionals to inspect their Rifampin vials for discoloration before dispensing or administering them. The letter included photos of ‘acceptable’ and ‘unacceptable’ vials and reconstituted solution.

Pfizer said the discoloured product should be discarded.

Companies