Friday, 13 May 2016 14:35

Recall Of Some Batches Of Children Medication

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The Agency has been notified of the Singaporean Health Science Authority (HSA) recall of two (2) batches of children’s’ Guaifenesin grape liquid (100mg/5ml) and three (3) batches of children’s’ Guaifenesin DM cherry liquid (100mg Guaifenesin and 5mg dextromethorphan HBr/5ml) contained in 4 oz. bottles with oral dosage cups in a box under multiple store brand product names. The recall was due to some packages containing oral dosing cups with incorrect dose markings. The products are indicated for helping loosen phlegm (mucus) and thin bronchial secretions, and in the case of the DM product to temporarily relieve: coughs due to minor throat irritations, the intensity of coughing, and the impulse to cough.

Possible risk associated with the affected batches

  • Poor metabolizers of dextromethorphan may experience an overdose by a factor of 3, if incorrect measuring levels are used. Therefore, children who are poor metabolizers of dextromethorphan and use the product regularly over a period of several days at the mistaken dose, may develop cumulative toxicity
  • Overdose of Guaifenesin DM may cause hyper excitability, rapid eye movements, changes in muscle reflexes, ataxia, dystonia, hallucinations, stupor, and coma. Other effects have included nausea, vomiting, tachycardia, irregular heartbeat, seizures, respiratory depression, and death in extreme cases.

Details of the affected lots are as follows:

GUAIFENESIN GRAPE LIQUID 4 OZ

Label                     Lot number                   Expiry
H.E.B                        5LK0592                     08/2017
CVS                        5MK0340                     08/2017

GUAIFENESIN DM CHERRY LIQUID 4 OZ

Label          Lot number                  Expiry
Sunmark         5LK0528, 5LK0630                03/2017
Rite-Aid         5LK0528, 5LK0630                03/2017
Topcare         5LK0528, 5LK0630, 5LK0779                03/2017
Kroger         5LK0528, 5LK0630                03/2017
GoodSense         5LK0528                03/2017
Dollar General         5LK0630                03/2017
Care One         5LK0630                03/2017
CVS         5LK0630                03/2017

NAFDAC implores importers and healthcare providers to exercise caution and discontinue the purchase, administration and use of these products.

NAFDAC implores all outlets with this product to immediately withdraw them from the market.

Healthcare providers should report all adverse events to NAFDAC PRASCOR (20543-Toll free from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it.

NAFDAC…..Safeguarding the health of the Nation!!!

Read 4957 times Last modified on Friday, 13 May 2016 19:36

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