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CLARIFICATION ON RECALLED MEDICINES

Tuesday, 1st November 2016

           CLARIFICATION ON RECALLED MEDICINES

National Drug Authority (NDA) wishes to refer to theSaturday Vision - October 29, 2016 

(Recalled drugs still on the market). NDA recalledspecific batches of six products from the market. 

Namely;

PRODUCT NAME

GENERIC NAME

BATCH NUMBER

MANUFACTURER

REASONS FOR RECALL

UNIVITTAL

Multivitamin

BUV-14002

Unichem Laboratories Ltd, India

Poor quality gelatin capsules (capsules stick to the Aluminum foil package)

HYDRAPRES INJECTION

HYDRALAZINE INJECTION

15E31A

Laboratorios, SA-Bercelona, Spain

Powder cakes within the ampoule

AGONAL

Nalidixic Acid

T52047

Agog Pharma Ltd, India

Tablets turn moldy and black

 

Vitamin B Complex

131017

Anhui Chengshi Manufacture Medicine Co., China

Contains suspended dark particles

LYOPOX + PPR

Sheep Pox And Peste Des Petits Ruminants Vaccine

15LPPB003

MCL Santé Animale, Morocco

Did not comply with OIE Specifications for potency of PPR IFA method

NETVAICAIN PLAIN

Bupivacaine Injection BP 0.5%

SX-16117

Swiss Parenterals PVT. LTD, 809, Kerala G.I.D.C., Nr. Bavla Ahmedabad-382 220, Gujara, INDIA

Wrongly labeled with “For IV use only” contrary to the acceptable method of administration

The specific batches recalled can be identified by the respective batch numbers shown in red colour above.  It should be noted that the recall applies to only these batch numbers of the respective products that were found to be defective. This recall does NOT affect other batches that are not listed above.

The public is therefore hereby informed that it is only those six batch numbers for the six drug products that were recalled by National Drug Authority.

Protecting the human and animal population from poor quality, unsafe and ineffective drugs is a collective responsibility. The public is therefore advised to be vigilant and be on the look-out for the recalled batches only.

Information relating to the recalled products can be obtained or must be submitted to National Drug Authority on

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