**Executive Summary:**
This document pertains to the voluntary recall of Digene Gel, manufactured by Abbott India Limited, due to safety concerns. It was issued by the Government of India's Central Drugs Standard Control Organization (CDSCO) on August 7, 2023. The recall affects all batches manufactured at the Goa facility and requires immediate action from distributors, retailers, and consumers.
**Key Points / Main Content:**
* **Subject:** Voluntary Recall of Digene Gel
* **Manufacturer:** Abbott India Limited, L18 19, verna I u o A 9 bn a AM b ms b bd
* **Reason for Recall:** Not specified in the text.
* **Scope of Recall:**
* All batches of Digene Gel manufactured at the Goa facility.
* Batch numbers include: A 9 bn a AM b ms b bd 0 a n B a ae su b t2 d tss d ne o c3 cRt ur t h v r hAb v f dt o Ai ey ala a b sI o I Ed utl cbt n .C n Pe tod o E uw ti Dd ui 5 fts ts aa a r t 1 tr1t w s Da 0 e 0L y1o at i8 di 3e r m I gs 1m s 0, 0 ne e ei t a 8 dp 3tr o nS to 2io e Da f eap 02r dl i G 7 p0 2st ,c w G o 2 e 3e e Lho eL 3 adt id a if lt , m dnt 1e p io far e di o8, t arn e t f cn eoG c eD i df dg u 1 loo adi ,o u il 9 lt l a g tlr ca ,o y1e m r tA Lu .fv 8n4 e i u r let e0 od T1 ag a r 0 nw3 8 v hu s Gn t 8 i o7 t es eoa o rte2 t l f 2 sh t 12 I i 0 h n o2 9a mi 2b ls d ,0 rs Mlr pi 3uw 2 ae it s ue vg o3 nt nvt. e iaf g, e g tr eft r nr i ,ei r i tt a e c na t ih l h Oe dna aa m a a r tEsn f at v as st o pt d it nIeo r re oa n n g n d ol vt f dga e i de oe u ng ,tD us, l bh d o t cb iu at S r M o tgn ta i tt p ip t el c a ht ui a mxnc lh il n n re e s ae k t y fg n yt E ro Goeo c re s uf e.f n e t, io f b l ct a t il 5D eaG st c o mi l fg e.
* **Implementation:**
* Distributors and retailers must remove the affected product from shelves.
**Impact Analysis:**
* **Abbott India Limited:**
* *Impact:* Responsible for executing the voluntary recall and managing the return of affected products.
* *Action Required:* Coordinate the recall process, communicate with distributors and retailers, and address consumer concerns.
* **Distributors and Retailers:**
* *Impact:* Must remove affected Digene Gel from distribution and retail channels.
* *Action Required:* Stop the sale and distribution of the affected product, and coordinate returns with Abbott India Limited.
* **Consumers:**
* *Impact:* Consumers who have purchased Digene Gel from the specified batches should discontinue use.
* *Action Required:* Not specified
* **Central Drugs Standard Control Organization (CDSCO):**
* *Impact:* Oversees the recall process and ensures compliance.
* *Action Required:* Monitor the effectiveness of the recall and provide guidance to Abbott India Limited as needed.
Key Entities Referenced
Digene Gel: A medication that is the subject of a voluntary recall.
Abbott India Limited: The manufacturer of Digene Gel.
Verna, Goa: Location of manufacturing plant of Abbott India Limited.
Drugs Controller General: A position or title within the Indian government, responsible for drug regulation.
Dr. Rajeev Singh Raghuvanshi: Individual holding the position of Drugs Controller General.
AIOCD: Acronym for All India Organization of Chemists and Druggists.
Mumbai, Maharashtra: Location of AIOCD office.
Nirman Bhawan, New Delhi: Location of Ministry of Health and Family Welfare office.
ED/Complaint/223/2023
Government of India
CentD ri ar le c Dt ro ura gt se SG te an ne dr aa rl d o Cf o H ne ta rl ot lh O S re gr av ni ic ze as tion
(Enforcement Division)
Dated:- gy AUG 2013
Subject:- Voluntary Recall of Digene Gel
manufactured by M/s Abbott India Limited, L-18 /19, verna
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(Dr. Rajeew/Singh Raghuvdnashi)
Drugs Wontroller General (I)
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