Thursday, December 2, 2010

Recall of Mylanta and Alternagel Liquid Products

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.

Product
NDC Number
Lot Number
UPC
MYLANTA® REGULAR STRENGTH ORIGINAL 12 FL OZ
16837-162-12
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
716837610120
MYLANTA® ORIGINAL 5 FL OZ
16837-162-55
AAF071, AAF072, ADF048
ADF049, AFF016, AFF032
AJF038, AJF039, ASF056
BCF038, BDF046, BEF052
BFF003, BMF003, SSF053
716837610557
MYLANTA® REGULAR STRENGTH MINT 12 FL OZ
16837-138-12
ADF026, BCF037,
BHF028, SSF006
716837629122
MYLANTA® MAXIMUM STRENGTH CHERRY 12 FL OZ
16837-136-12
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
716837622123
MYLANTA® MAXIMUM STRENGTH MINT 12 FL OZ
16837-137-12
AAF091, ABF081, ACF039
ADF062, AEF030, AFF031
AHF015, ALF027, AMF033
APF063, BAF046, BCF035
BDF030, BEF028, BEF056
BFF018, BHF004, BJF018
BJF040, BJF041, BLF016
SPF067, SSF016
716837624127
MYLANTA® MAXIMUM STRENGTH ORIGINAL 12 FL OZ
16837-163-12
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
716837652120
MYLANTA® MAXIMUM STRENGTH ORIGINAL 24 FL OZ
16837-163-24
AAF018, AAF023, ABF034
ABF066, ACF021, ACF027
ADF024, AHF035, AHF037
AJF025, ALF028, AMF039
ASF054, BAF014, BBF029
BCF084, BEF011, BEF023
BFF017, BHF006, BJF037
716837652243
MYLANTA® ULTIMATE STRENGTH MINT 12 FL OZ
16837-643-12
AJF008, ASF017
BDF017, BDF017A
716837643128
MYLANTA® ULTIMATE STRENGTH CHERRY 12 FL OZ
16837-644-12
ABF078, ADF013, ADF093
AFF015, AHF043, AJF006
AJF006A, ALF004, AMF026
APF031, ASF055, BBF014
BBF014A, BDF001, BDF055
BEF030, BHF024, BJF006
BJF019, BLF002, SPF024
716837644125
MYLANTA® SUPREME TASTING WITH CALCIUM CHERRY 12 FL OZ
16837-825-12
ACF040, AEF029, AHF045
ALF051, ASF040, BBF015
BEF026, BHF001, BJF032
SPF068
716837825128
MYLANTA® SUPREME TASTING WITH CALCIUM CHERRY 24 FL OZ
16837-825-24
AAF090, ADF023, AHF042
AMF040, BCF083, BHF038
716837825241
MYLANTA® MAXIMUM STRENGTH ORIGINAL 12 FL OZ
16837-163-12
0089N11, 0089N11A, 0089N11B
0369N11, 0369N21, 0559N28
0689N12, 0689N22, 1069N21A
1079N11, 1209N22A, 1219N12
1219N22, 1569N12, 1569N12A
1569N22, 2229N11, 2229N21
3068N12, 3588N21
716837652151
ALTERNAGEL® 12 FL OZ
16837-860-12
ADF012, ASF057, BLF006
716837860129
 

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