Tylenol recall 2009

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McNell Consumer Healthcare and Food and Drug Administration notified consumers of a nationwide recall of certain Tylenol products because of potential manufacturing problems.

The notice was posted on the FDA website on Sept 25 although the company actually initiated a recall of certain oral suspension Children's and Infants' TYLENOL products distributed between March 2008 and May 2009 because of potential contamination of bacteria in raw materials used for the products.

In a letter dated Sept 18, 2009 and addressed to healthcare professional, Dr. Edwin K. Kuffner, vice president - Medical Affairs at McNell Consumer Healthcare says his company is voluntarily recalling certain lots of Children's and infants' Tylenol products that were manufactured between April 2008 and June 2008.

The trigger for the Tylenol recall is that the gram-negative bacteria Burkholderia cepacia (B. cepacia) was found in raw material. The portion of tainted raw material was not used in the production of any finished product. But as a precaution, McNell decided to recall all products that utilized any of the raw material at the same time the contamination was detected.

The company said no bacteria has been found in finished product and the finished product has met all specifications. And the FDA said no illness has been found associated with the recalled Tylenol products.

The following are the list of Tylenol products subjected to the recall.

 

UPC # | Code # | Lot # | Product Description

 

300450391049 | 3910400 |  SBM041, SBM067, SCM037, SDM027, SEM109 | Children's TYLENOL® Plus Cold MS, Suspension 4 oz. Grape

300450296047 | 2960400 | SBM042, SCM015, SCM036, SDM034 | Children's TYLENOL® Suspension 4oz.  Grape

300450407047 | 4070400 | SBM043, SBM044, SCM029 | Children's TYLENOL® Suspension 4oz. Bubble Gum

300450493040 | 4930400 | SBM045, SCM011, SCM030, SDM035 | Children's TYLENOL® Suspension 4oz. Strawberry

300450122407 | 1224000 | SBM064, SCM033, SDM020 | Infants' TYLENOL® Grape Suspension, Drops 1/4oz.

300450186157 | 1861500 | SBM065, SCM005, SCM006, SDM032 | Infants' TYLENOL® Suspension 1/2oz. Cherry

300450166043 | 1660400 | SBM066, SCM068 | Children's TYLENOL® Dye Free, Suspension 4oz. Cherry

300450123046 | 1230400 | SBM068, SCM035, SCM070, SCM080, SDM005 | Children's TYLENOL® Suspension 4oz.  Cherry

300450249043 | 2490400| SBM069, SBM070, SCM081, SDM006 | Children's TYLENOL® Plus Cough & Runny Nose 4oz. Cherry

300450122155 | 1221500 | SCM012, SCM067, SDM007, SDM068 | Infants' TYLENOL® Suspension Drops 1/2oz. Grape

300450386045 | 3860400 | SCM013, SCM014, SCM069 | Children's TYLENOL® Plus Flu 4oz. Bubble Gum

300450387042 | 3870400 | SCM016, SFM024 | Children's TYLENOL® Plus Cold Suspension 4oz. Grape

300450247049 | 2470400 | SCM017 |  Children's TYLENOL® Plus Cough/ST Suspension 4oz. Cherry

300450122018 | 1220100 | SCM082, SDM039, SDM040 | Infants' TYLENOL® Suspension Drops 1oz. Grape

300450167019 | 1670100 | SCM083, SCM084, SDM008 | Infants' TYLENOL® Dye Free Suspension 1oz. Cherry

300450123015 | 1230100 | SDM064 | Children's TYLENOL® Pediatric Suspension 1oz. Cherry

300450186300 |1863000 | SDM038, SDM009 Infants' TYLENOL® Suspension Drops 1oz. Cherry

300450390042 | 3900400 | SDM033 | Children's TYLENOL® Plus Cold/Allergy 4oz. Bubble Gum

300450122100 | 1221000 | SDM078 | Infants' TYLENOL® Drops 1oz. Grape

350580144183 | 1221800 | SCM034 | Infants' TYLENOL® Grape Suspension Drops H/G 1/2oz.

350580123034 |1230300 |SDM028 | Children's TYLENOL® Suspension 4oz. Cherry, Hospital Govt.

By David Liu davidl at foodconsumer dot org

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