Recalls & Alerts Published by NAFDAC

Wednesday, 20 December 2017 15:04

Warning On Homoeopathic Teething Tablets

The National Agency for Food and Drug Administration and Control has been informed that the Singapore’s Health Sciences Authority (HSA), on 11th October 2017, disclosed that it had received a direct foreign drug alert from Australia’s Therapeutic Good’s Administration (TGA), informing it that Kadac, Australia’s largest manufacturer and distributor of organic, natural and health products, was recalling all batches of Hyland’s Baby teething tablets and Hyland’s Baby night time teething tablets following an investigation which revealed that the product contains inconsistent amount of belladonna alkaloids, a toxic substance which poses potential safety risk to children.

Hyland’s homeopathic teething tablets are complimentary medicines marketed to provide temporary relief of teething symptoms in children. Consumers should stop using the product immediately and return unused portions to the nearest NAFDAC office for disposal.

NAFDAC implores consumers and all outlets with these products to immediately stop theiruse, sale and distribution and submit them to the nearest NAFDAC office for appropriate action.

Report adverse events relating to the use of these products 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!!!

Wednesday, 20 December 2017 15:00

Recall Of Rhino 7 Platinum 5000 Capsules

The National Agency for Food and Drug Administration and Control have been informed that the Hungarian Institute of Pharmacy and Nutrition (OGYEI) had on 5th October, 2017 disclosed that Gadget Island, Inc., manufacturers of Rhino 7 Platinum 5000 capsules, issued a recall order on lots of their products which were found to be tainted with Sildenafil, Tadalafil and DesmethylCarbodenafil. The use of products containing the listed ingredient by persons on diabetic, hypertensive and heart disease medications is life-threatening, as they may interact with nitrates, to cause a significant drop in blood pressure.

Sildenafil and Tadalafil are the active ingredients used for the treatment of erectile dysfunction (ED). DesmethylCarbodenafil is also structurally similar to Sildenafil. Below is the details of the affected products;

Producer’s Name: Gadget Island Inc.

Product Name Package Size UPC Lot# and Exp. date
Rhino 7 Platinum 5000 1 Capsule in blister pack 617135 861224

R7-D5K1011H

EXP: 12/2017

Papa Zen 3300

1 Capsule in blister pack

718122

032587

NSS050888

EXP: May 2018

Fifty Shades 6000

1 Capsule in blister pack

4026666

146056

All Lots
Grande X 5800

1 Capsule in blister pack

640793

555440

All Lots

Healthcare Providers, facilities and consumers in possession of the affected products should immediately stop the dispensing and use of the products and report all adverse events resulting from the consumption of the product to the nearest NAFDAC office, 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!!!

Wednesday, 20 December 2017 14:44

Recall Of Vancomycin Hydrochloride For Injection

The National Agency for Food and Drug Administration and Control has been informed by the U.S Food and Drug Administration (FDA), that Hospira voluntarily recalled one lot of Vancomycin Hydrochloride for injection, USP, 750mg/vial to the hospital/ retailer level. The recall was due to a confirmed customer report for the presence of particulate matter, confirmed as glass in a single vial.

The administration of the particulate to a patient may result in phlebitis, end-organ granuloma or micro-embolic effects, or gastrointestinal trauma.

Vancomycin Hydrochloride is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant staphylococci.

The details of the recalled product are as follows;

Product Name -Vancomycin Hydrochloride for inj. USP, 750mg/vial.

Product Manufacturer -          Hospira Inc.

Lot Number -                           632153A

Expiry Date -               01 MAR 2018

NDC- 0409-6531-02

Healthcare Provider’s Action

Healthcare Providers should visually inspect the product for particulate matter and discoloration prior to administration.

Healthcare Providers in possession of this batch of the product should immediately stop administration, sale or use of the product and submit them to the nearest NAFDAC office.

Healthcare providers and patients should report adverse reactions associated with the use of these product to the nearest NAFDAC office, NAFDAC PRASCOR 920543 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!!!

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