Silver Spring, Maryland–(ENEWSPF)–December 1, 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.
|
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 |
Source: fda.gov
