notyard
09-25-2009, 01:26 PM
From McNeil's website--one of their ingredients turned out to test positive for Burkholderia cepacia bacteria:
September 24, 2009
You may have heard that McNeil Consumer Healthcare (the makers of TYLENOL®) is voluntarily recalling certain lots of Children's and Infants' TYLENOL® liquid products that were manufactured between April, 2008 and June, 2008. All products manufactured met internal specifications. However, the company is implementing this recall because during this period, an unused portion of one inactive ingredient did not meet all quality standards. Therefore, as a precautionary measure, it was decided to recall all Children's and Infants' TYLENOL® liquid products listed below, which were made during this time.
Parents and caregivers who have questions or concerns should contact their child's health care provider or our consumer call center at 1-800-962-5357 (available Monday-Friday 8 a.m. to 8 p.m. Eastern Time). Consumers can find the lot numbers on the bottom of the box containing the liquid product and also on the sticker that surrounds the product bottle. The lot numbers of the affected products are listed below.
These actions do not apply to Children's TYLENOL® Meltaways and Junior Strength TYLENOL® Meltaways. The voluntary recall applies only to select lots of Children's and Infants' TYLENOL® liquid products.
Recalled Products - Full List
Lot # Product Description
SBM041, SBM067, SCM037, SDM027, SEM109 Children's Tylenol Plus Cold MS Suspension 4 oz. Grape
SBM042, SCM015, SCM036, SDM034 Children's Tylenol Suspension 4oz. Grape
SBM043, SBM044, SCM029 Children's Tylenol Suspension 4oz. Bubble Gum
SBM045, SCM011, SCM030, SDM035 Children's Tylenol Suspension 4oz. Strawberry
SBM064, SCM033, SDM020 Infant’s Tylenol Grape Suspension Drops 1/4oz.
SBM065, SCM005, SCM006, SDM032 Infant's Tylenol Suspension 1/2oz. Cherry
SBM066, SCM068 Children's Dye Free Suspension 4oz. Cherry
SBM068, SCM035, SCM070, SCM080, SDM005 Children's Tylenol Suspension 4oz. Cherry
SBM069, SBM070, SCM081, SDM006 Children's Tylenol Plus Cough & Runny Nose 4oz. Cherry
SCM012, SCM067, SDM007, SDM068 Infant's Tylenol Suspension Drops 1/2oz. Grape
SCM013, SCM014, SCM069 Children's Tylenol Plus Flu 4oz. Bubble Gum
SCM016, SFM024 Children's Tylenol Plus Cold Suspension 4oz. Grape
SCM017 Children's Tylenol Plus Cough/ST Suspension 4oz. Cherry
SCM082, SDM039, SDM040 Infant's Tylenol Suspension Drops 1oz. Grape
SCM083, SCM084, SDM008 Infant's Tylenol Dye Free Suspension 1oz. Cherry
SDM064 Children’s Tylenol Pediatric Suspension 1oz. Cherry
SDM038, SDM009 Infant's Tylenol Suspension Drops 1oz. Cherry
SDM033 Children's Tylenol Plus Cold/Allergy 4oz. Bubble Gum
SDM078 Infant's Tylenol Drops 1oz. Grape
SCM034 Infant’s Tylenol Grape Suspension Drops H/G 1/2oz.
SDM028 Children's Tylenol Suspension 4oz. Cherry, Hospital Govt.
notyard
09-26-2009, 11:34 AM
Here's the letter dated September 18th, 2009, that McNeil sent out to healthcare professionals--contains more details about the bacteria found in the ingredient (but not the actual Tylenol products) and decision on what to recall:
September 18, 2009
Dear Healthcare Professional:
I am writing to inform you that, in consultation with the U.S. Food and Drug Administration (FDA), McNeil
Consumer Healthcare is voluntarily initiating a recall of certain lots of Children's and Infants' TYLENOL®
products that were manufactured between April 2008 and June 2008. The full list of recalled product lots is below.
The company has implemented this recall because examination of bulk raw material detected that one of
the inactive ingredients did not meet internal testing requirements. Specifically, the gram-negative bacteria Burkholderia cepacia (B. cepacia) was detected. The portion of raw material in which the bacteria was found was isolated and was not used in the production of any finished product. However, it was decided, as a precaution, to recall all product that utilized any of the raw material manufactured at the same time as the raw material that tested positive for the bacteria. Please note: No bacteria has been detected in finished product and the finished product has met all specifications.
A review of the relevant published scientific literature regarding B. cepacia indicates that while ingestion of contaminated pharmaceutical product is not known to be a route of transmission of B. cepacia infection,
infection has been reported following the use of contaminated pharmaceutical products such as
mouthwashes and nasal sprays. Adverse health consequence of B. cepacia infections could be potentially
severe especially in high-risk patients, such as those with underlying pulmonary disease, cystic fibrosis or
compromised immune systems.
McNeil has conducted an assessment of post-marketing safety surveillance data and did not identify any
safety signals or batch-related safety concerns for Infants' and Children's TYLENOL® products over the
time period, starting with the introduction of these batches, in or around April 2008.
McNeil is advising parents and caregivers who have administered affected product to their child or infant
and have concerns to contact their healthcare providers. Parents and caregivers can find the lot numbers
on the bottom of the box containing the product and also on the sticker that surrounds the product bottle. If
your patients determine that they have affected product, they can contact our Customer Care Center at 1-
800-962-5357 and we will send them a coupon for a new bottle.
If you have any questions, please call our Medical Affairs Department at 1-800-962-5357 (available
Monday-Friday 8 a.m. to 8 p.m. Eastern Time).
Sincerely,
(signed)
Edwin K. Kuffner, MD
Vice President, Medical Affairs
McNeil Consumer Healthcare
Recalled Products - Full List
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.
notyard
10-01-2009, 02:54 PM
FDA class II recall of 7,983,648 bottles still in progress:
PRODUCT
1) Children's Tylenol Plus, Multi-Symptom Cold, (each 5 mL contains: Acetaminophen 160 mg, Chlorpheniramine maleate 1 mg, Dextromethorphan HBr 5 mg, and Phenylephrine HCl 2.5 mg), 4 fl oz (120 mL) bottles, Grape Flavor, **** Suspension, Product code 3910400, UPC 300450391049. Recall # D-1952-2009;
2) Children's Tylenol, (acetaminophen 160 mg/5 mL), 4 fl oz (120 mL) bottle, Grape Flavor **** Suspension. Product code 2960400, UPC 300450296047. Recall # D-1953-2009;
3) Children's Tylenol, (acetaminophen 160 mg/5 mL), 4 fl oz (120 mL) bottle, bubblegum Yum Flavor, **** Suspension. Product code 4070400, UPC 300450407047. Recall # D-1954-2009;
4) Children's Tylenol, (acetaminophen 160 mg/5 mL), 4 fl oz (120 mL) bottle, very berry Strawberry Flavor, **** Suspension. Product code 4930400, UPC 300450493040.Recall # D-1955-2009;
5) Concentrated Tylenol, Infants' Drops, (acetaminophen 80 mg/0.8 mL), Grape Flavor. Packaged in the following configurations: 1/4 fl oz (7.5 mL) bottle with dropper, a) Product code 1224000, UPC 300450122407; 1/2 fl oz (15 mL) bottle with dropper, b) Product code 1221500, UPC 300450122155; 1 fl oz (30 mL) bottle with dropper, c) Product code 1220100, UPC 300450122018; 1 fl oz (30 mL) bottle with dropper, d) Product code 1221000, UPC 300450122100; (For Hospital/Government Use Only), 1/2 fl oz (15 mL) bottle, e) Product code 1221800, UPC 350580144183. Recall # D-1956-2009
6) Concentrated Tylenol, Infants' Drops, (acetaminophen 80 mg/0.8 mL), Cherry Flavor. Packaged in the following configurations: 1/2 fl oz (15 mL) bottle with dropper, a) Product code 1861500, UPC 300450186157; 1 fl oz (30 mL) bottle with dropper, b) Product code 1863000, UPC 300450186300; (For hospital/government use only), 4 fl oz (120 mL) bottle, c) Product code 1230300, UPC 350580123034. Recall # D-1957-2009;
7) Children's Tylenol, (acetaminophen 160 mg/5 mL), 4 fl oz (120 mL) bottle, Dye Free Cherry Flavor, **** Suspension. Product code 1660400, UPC 300450166043. Recall # D-1958-2009;
8) Children's Tylenol, (acetaminophen 160 mg/5 mL), Cherry Blast Flavor, **** Suspension. Packaged in the following configurations: 4 fl oz (120 mL) bottle, Product code 1230400, UPC 300450123046; 1 fl oz (30 mL) bottle, Product code 1230100, UPC 300450123015. Recall # D-1959-2009;
9) Children's Tylenol Plus, Cough & Runny Nose, (each 5 mL contains: Acetaminophen 160 mg, Chlorpheniramine maleate 1 mg, and Dextromethorphan HBr 5 mg), 4 fl oz (120 mL) bottle, Cherry Flavor, **** Suspension. Product code 2490400, UPC 300450249043. Recall # D-1960-2009;
10) Children's Tylenol Plus Flu, (each 5 mL contains: Acetaminophen 160 mg, Chlorpheniramine maleate 1 mg, Dextromethorphan HBr 5 mg, and Phenylephrine HCl 2.5 mg), 4 fl oz (120 mL) bottle, Bubble Gum Flavor, **** Suspension. Product code 3860400, UPC 300450386045. Recall # D-1961-2009;
11) Children's Tylenol Plus Cold, (each 5 mL contains: Acetaminophen 160 mg, Chlorpheniramine maleate 1 mg, and Phenylephrine HCl 2.5 mg), 4 fl oz (120 mL) bottle, Grape Flavor, **** Suspension. Product code 3870400, UPC 300450387042. Recall # D-1962-2009;
12) Children's Tylenol Plus Cough & Sore Throat, (each 5 mL contains: Acetaminophen 160 mg and Dextromethorphan HBr 5 mg), 4 fl oz (120 mL) bottle, Cherry Flavor, **** Suspension. Product code 2470400, UPC 300450247049. Recall # D-1963-2009;
13) Concentrated Tylenol Infants' Drops, (acetaminophen 80 mg/0.8 mL), 1 fl oz (30 mL) bottle with dropper, Dye-Free Cherry Flavor. Product code 1670100, UPC 300450167019. Recall # D-1964-2009;
14) Children's Tylenol Plus Cold & Allergy, (each 5 mL contains: Acetaminophen 160 mg, Diphenhydramine HCl 12.5 mg, and Phenylephrine 2.5 mg), 4 fl oz (120 mL) bottle, Bubble Gum Flavor, **** Suspension. Product code 3900400, UPC 300450390042. Recall # D-1965-2009
CODE
1) Lot numbers: SBM041 exp 1/10, SBM067 exp 2/10, SCM037 exp 2/10, SDM027 exp 3/10, and SEM109 exp 5/10;
2) Lot numbers: SBM042 exp 2/10, SCM015 exp 2/10, SCM036 exp 2/10, and SDM034 exp 3/10;
3) Lot numbers: SBM043 exp 2/10, SBM044 exp 2/10, and SCM029 exp 2/10;
4) Lot numbers: SBM045 exp 2/10, SCM011 exp 2/10, SCM030 exp 2/10, and SDM035 exp 3/10;
5) a) Lot numbers: SBM064 exp 2/10, SCM033 exp 3/10, and SDM020 exp 3/10; b) Lot numbers: SCM012 exp 2/10, SCM067 exp 3/10, SDM007 exp 3/10, and SDM068 exp 3/10; c) Lot numbers: SCM082 exp 3/10, SDM039 exp 3/10, and SDM040 exp 3/10; d) Lot number: SDM078 exp 3/10; e) Lot number: SCM034 exp 2/10;
6) a) Lot numbers: SBM065 exp 2/10, SCM005 exp 2/10, SCM006 exp 2/10, and SDM032 exp 3/10; b) Lot numbers: SDM038 exp 3/10 and SDM009 exp 3/10; c) Lot number: SDM028 exp 3/10;
7) Lot numbers: SBM066 exp 2/10 and SCM068 exp 2/10;
8) Lot numbers: SBM068 exp 2/10, SCM035 exp 2/10, SCM070 exp 3/10, SCM080 exp 3/10, and SDM005 exp 3/10; Product code 1230100, Lot number: SDM064 exp 3/10;
9) Lot numbers: SBM069 exp 2/10, SBM070 exp 2/10, SCM081 exp 3/10, and SDM006 exp 3/10;
10) Lot numbers: SCM013 exp 2/10, SCM014 exp 2/10, and SCM069 exp 3/10;
11) Lot numbers: SCM016 exp 2/10 and SFM024 exp 5/10;
12) Lot number: SCM017 exp 2/10;
13) Lot numbers: SCM083 exp 3/10, SCM084 exp 3/10, SDM008 exp 3/10;
14) Lot number: SDM033 exp 3/10
RECALLING FIRM/MANUFACTURER
McNeil Consumer Healthcare, Div of McNeil-PPC, Inc., Fort Washington, PA, by letters dated August 21, 2009 and September 11, 2009. Firm initiated recall is ongoing.
REASON
The raw material used to manufacture the finished product may have been contaminated with B cepacia.
VOLUME OF PRODUCT IN COMMERCE
7,983,648 bottles
DISTRIBUTION
Nationwide
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