Table 3.
Substandard medicines subjected to urgent recalls (Health Product Recall type I and Public Warning) with other defect types
| Type of defect | Medications (number of incidents) | Formulation | Defect description |
|---|---|---|---|
| Major packaging defects (incorrect labelling) | Trazodone (1), amlodipine (1) and fluvoxamine (1) | Tablets | Some products contained the wrong medicines due to labelling errors (eg, amlodipine instead of minocycline, minocycline instead of amlodipine, clonazepam instead of rifampicin and fluphenazine instead of octreotide) or filling errors (eg, nabilone instead of trazodone, ciprofloxacin instead of fluvoxamine, trazodone instead of nabilone, isoproterenol instead of morphine and blue collyrium instead of prednisolone) |
| Nabilone (1), minocycline (1) and rifampicin (1) | Capsules | ||
| Morphine sulfate (1) and octreotide acetate omega (1) | Solution for injection | ||
| Prednisolone (1)* | Ophthalmic solution | ||
| Haemodialysis acid aoncentrates (1), remifentanil HCl (1), pamidronate disodium (1), tobramycin (1) and triamcinolone acetonide (1) | Solution for injection | Wrong strength, dosage or expiry date were printed on the packaging | |
| Sodium solysterene sulfonate (1) | Suspension | ||
| Acetaminophen (1) | Suppositories | ||
| Personnelle cold and flu tablets (2), acetylsalicylic acid (1), acetaminophen (1) and personelle acid control (1) | Tablets | Important mandatory warning statement was missed on the external packaging | |
| Oral contraceptive pills (4) | Tablets | Additional placebo tablet was found in place of an active tablet in one blister pack raising the risk of unwanted pregnancy | |
| Ibuprofen (2) | Tablets Tablets | The label stated that the bottle had a child resistant cap, but the cap used was not child resistant | |
| Stability defects | Smallpox vaccine (1) | Solution for injection | Evidence of instability based on its appearance |
| Timolol (1) | Ophthalmic solution | Active ingredient was out of specification after 12 month of production date | |
| Valproic acid (1) | Capsules | Disintegration test failure within the shelf life of the drug | |
| Amoxicillin (1) | Suspension | Out of specification assay result was obtained at various time points | |
| Active ingredients defects | Phenobarbital (1)* and morphine SR (1) | Tablets Tablets |
Oversized tablets were found raising the risk of overdose |
| Acetylsalicylic acid (1) | Inadequate amount of active ingredient | ||
| Delflex (1)and carmustine (1) | Solution for injection | Excessive amount of active ingredients | |
| Ethacrynic acid (1) | Inadequate amount of active ingredient | ||
| Delivery defects | Paliperidone palmitate (1), nutrineal (1), degarelix (1), caspofungin acetate (1), vancomycin (1) and argatroban (1) | Solution for injection Solution for injection Solution for injection | Cracks in the syringes or vials, or leaks from the bags were identified raising the risk of contamination |
| Sumatriptan (1) | Prefilled syringes were filled with needles that protruded through the needle shield | ||
| Morphine sulfate (1) | Plunger friction with the vial may cause pump occlusion or delivery of inaccurate dose | ||
| Cough and cold syrup (9) | Syrup | The child-resistant feature of the bottle cap was not functioning properly | |
| Other | Hypromellose (1) | Lubricant eye gel | Non-compliance with Good Manufacturing Practices |
*Medicine was reported using the Public Warning document. Others were reported using Health Product Recall type I.