Recall of Mylanta and Alternagel Liquid Products1 December 2010, 2:21 pm Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. Recall of Mylanta and Alternagel Liquid Products
Contact: Consumer Care Center
1-800-469-5268
FOR IMMEDIATE RELEASE – November 29, 2010 - In consultation with the U.S.
Food and Drug Administration(FDA), Johnson & Johnson-Merck Consumer Pharmaceuticals, Co. (JJMCP) is recalling, from the wholesale and retail level, twelve MYLANTA
? liquid products and one AlternaGEL
? liquid product. JJMCP is conducting the recall in order to update the labeling for these products. The specific products involved, listed below, are being recalled in the United States and Puerto Rico.
JJMCP initiated the recall after an internal review revealed that information about the presence of alcohol from flavoring agents was not noted on the packaging. Certain flavoring agents contribute small (< 1%) amounts of alcohol. It is unlikely that use of these products will cause either alcohol absorption or alcohol sensitivity related adverse events.
This is a wholesale and retail level recall and is not being undertaken on the basis of adverse events. No action is required by consumers or healthcare providers and consumers can continue to use the product.
Consumers with questions should call our Consumer Care Center at 1-800-469-5268 (available Monday-Friday from 8 a.m. – 8 p.m. ET and Saturday – Sunday, 9 a.m. – 5 p.m. Eastern Time.)
The NDC codes and lot numbers for the recalled products can be found in the below list and on the bottle.
[td]
NDC Number
[/td] [td]
Lot Number
[/td] [td]
UPC
[/td] [tr] [td]MYLANTA
? REGULAR STRENGTH ORIGINAL 12 FL OZ[/td] [td]
16837-162-12
[/td] [td]
AAF075, ABF005, ABF033
ABF068, ACF008, ACF054
ADF063, AEF024, AHF004
AHF016, AHF051, AJF026
ALF030, AMF016, AMF046
AMF047, APF064, APF074
ASF041, BAF028, BAF045
BAF049, BBF008, BCF051
BDF026, BDF045, BEF029
BEF043, BFF001, BFF020
BHF029, BHF031, BHF032
BJF017, BJF045, BJF046
BJF047, BLF025, BMF004
BMF023, SSF064, SSF078
[/td] [td]
716837610120
[/td] [/tr] [tr] [td]MYLANTA
? ORIGINAL 5 FL OZ[/td] [td]
16837-162-55
[/td] [td]
AAF071, AAF072, ADF048
ADF049, AFF016, AFF032
AJF038, AJF039, ASF056
BCF038, BDF046, BEF052
BFF003, BMF003, SSF053
[/td] [td]
716837610557
[/td] [/tr] [tr] [td]MYLANTA
? REGULAR STRENGTH MINT 12 FL OZ[/td] [td]
16837-138-12
[/td] [td]
ADF026, BCF037,
BHF028, SSF006
[/td] [td]
716837629122
[/td] [/tr] [tr] [td]MYLANTA
? MAXIMUM STRENGTH CHERRY 12 FL OZ[/td] [td]
16837-136-12
[/td] [td]
AAF022, ABF004, ABF067
ACF016, ADF011, ADF090
AEF051, AFF038, AHF003
AJF010, ALF050, APF028
BAF023, BCF010, BCF071
BCF086, BDF056, BEF054
BFF019, BFF034, BFF035
BFF042, BHF003, BJF005
BJF030, BMF005, BMF024
SPF066, SSF017, SSF051
SSF073
[/td] [td]
716837622123
[/td] [/tr] [tr] [td]MYLANTA
? MAXIMUM STRENGTH MINT 12 FL OZ[/td] [td]
16837-137-12
[/td] [td]
AAF091, ABF081, ACF039
ADF062, AEF030, AFF031
AHF015, ALF027, AMF033
APF063, BAF046, BCF035
BDF030, BEF028, BEF056
BFF018, BHF004, BJF018
BJF040, BJF041, BLF016
SPF067, SSF016
[/td] [td]
716837624127
[/td] [/tr] [tr] [td]MYLANTA
? MAXIMUM STRENGTH ORIGINAL 12 FL OZ[/td] [td]
16837-163-12
[/td] [td]
AAF073, AAF092, ACF007
ACF038, ACF059, ADF050
AEF025, AEF055, AEF060
AHF005, AHF044, AJF007
ALF049, APF076, ASF039
BAF009, BBF003, BCF036
BCF085, BDF034, BDF057
BEF031, BFF016, BHF011
BHF012, BHF027, BHF039
BJF011, BJF031, BLF001
BLF017, BMF018, BMF025
SSF014, SSF062, SSF075
[/td] [td]
716837652120
[/td] [/tr] [tr] [td]MYLANTA
? MAXIMUM STRENGTH ORIGINAL 24 FL OZ[/td] [td]
16837-163-24
[/td] [td]
AAF018, AAF023, ABF034
ABF066, ACF021, ACF027
ADF024, AHF035, AHF037
AJF025, ALF028, AMF039
ASF054, BAF014, BBF029
BCF084, BEF011, BEF023
BFF017, BHF006, BJF037
[/td] [td]
716837652243
[/td] [/tr] [tr] [td]MYLANTA
? ULTIMATE STRENGTH MINT 12 FL OZ[/td] [td]
16837-643-12
[/td] [td]
AJF008, ASF017
BDF017, BDF017A
[/td] [td]
716837643128
[/td] [/tr] [tr] [td]MYLANTA
? ULTIMATE STRENGTH CHERRY 12 FL OZ[/td] [td]
16837-644-12
[/td] [td]
ABF078, ADF013, ADF093
AFF015, AHF043, AJF006
AJF006A, ALF004, AMF026
APF031, ASF055, BBF014
BBF014A, BDF001, BDF055
BEF030, BHF024, BJF006
BJF019, BLF002, SPF024
[/td] [td]
716837644125
[/td] [/tr] [tr] [td]MYLANTA
? SUPREME TASTING WITH CALCIUM CHERRY 12 FL OZ[/td] [td]
16837-825-12
[/td] [td]
ACF040, AEF029, AHF045
ALF051, ASF040, BBF015
BEF026, BHF001, BJF032
SPF068
[/td] [td]
716837825128
[/td] [/tr] [tr] [td]MYLANTA
? SUPREME TASTING WITH CALCIUM CHERRY 24 FL OZ[/td] [td]
16837-825-24
[/td] [td]
AAF090, ADF023, AHF042
AMF040, BCF083, BHF038
[/td] [td]
716837825241
[/td] [/tr] [tr] [td]MYLANTA
? MAXIMUM STRENGTH ORIGINAL 12 FL OZ[/td] [td]
16837-163-12
[/td] [td]
0089N11, 0089N11A, 0089N11B
0369N11, 0369N21, 0559N28
0689N12, 0689N22, 1069N21A
1079N11, 1209N22A, 1219N12
1219N22, 1569N12, 1569N12A
1569N22, 2229N11, 2229N21
3068N12, 3588N21
[/td] [td]
716837652151
[/td] [/tr] [tr] [td]ALTERNAGEL
? 12 FL OZ[/td] [td]
16837-860-12
[/td] [td]
ADF012, ASF057, BLF006
[/td] [td]
716837860129
[/td] [/tr]
Source: Food and Drug Administration--Recalls/Safety Alerts
