Initial quality was a problem in four of 13 drugs tested. Ferrous sulfate tablets did not comply with pharmacopoeal specifications, but this was unlikely to have clinical consequences. Ampicillin injection showed moderate and retinol tablets and ergometrine injection serious problems of initial quality with potential clinical failure.
Individual samples of ferrous sulfate tablets were outside the specifications. Most failed samples had high values, particularly in the case of one manufacturer. The pharmacopoeal limits were narrow in relation to the therapeutic index and the outlying values had little medical significance, Ampicillin injection showed an unacceptable percentage of low failures (20%) with low potency: 14-17% below the stated content which had potential therapeutic significance. All the samples of retinol tablets failed; this was the case for both manufacturers' products. The mean assay value was 27% under the stated content, which was unacceptable even though the therapeutic margins were wide. Ergometrine injection had high failure rates (62% and 100%), most of which already occured in the first year of shelf-life. Only one sample was tested from third manufacturer (age 14.5 months) and it passed.
For ampicillin injection, retinol and ergometrine injection, supplier selection and careful routine testing for initial quality are recommended.