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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Recall of Tylenol Cold Liquid Products

In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling, from the wholesale and retail level, three TYLENOL® Cold Multi-Symptom liquid products in order to update the labeling for these products. The specific products involved, listed below, are sold in the United States.

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.

McNeil Consumer Healthcare initiated the recall after an internal review revealed that information about the presence of alcohol from flavoring agents was noted as an inactive ingredient listed on the package, but not on the front panel of the product. Certain flavoring agents contribute small (<1%) amounts of alcohol.

Consumers with questions should call our Consumer Care Center at 1-888-222-6036 (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 for the recalled products can be found on the product front panel.

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Bayer Consumer Care Voluntarily Recalls One Lot of Combination Package of Alka-Seltzer Plus(R) Day & Night Cold Formula Liquid Gels

/PRNewswire/ -- In consultation with the U.S. Food and Drug Administration (FDA), Bayer's Consumer Care division has begun a voluntary recall of a single product lot of the combination package of Alka-Seltzer Plus® Day & Night Cold Formula Liquid Gels. Bayer initiated the recall after identifying that the labeling on the foil blister card of certain packages within the lot (less than 4 percent) were printed with the label reversed. All individual liquid filled capsules are imprinted correctly.

The affected Alka-Seltzer Plus product lot number can be found on both the interior blister package (in black text adjacent to the expiration date) as well as on the exterior carton containing the blister packaging (embossed on the side panel under the Bayer logo).

-- Product Name: Alka-Seltzer Plus Day & Night Liquid Gels
-- Package size: 20 liquid filled capsules per carton (12 day
formulation capsules and 8 night formulation capsules)
-- UPC#: 016500537779
-- Lot #: 296939L
-- Expiration: 5/11
This product was sold only in the U.S. at retail outlets nationwide.


This recall does not impact any Alka-Seltzer Plus Day & Night Cold Formula Effervescent products, individually packaged Alka-Seltzer Plus Day Non-Drowsy Cold Formula products, individually packaged Alka-Seltzer Plus Night Cold Formula products, or any other lot of Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels.

The company initiated an investigation following consumer reports and found that in a limited number of combination packages of Alka-Seltzer Plus Day and Night Cold Formula Liquid Gels from a single lot, the information on the underside of the blister package was reversed. Therefore, the label for the green Night product appears under some of the blue Day product and vice versa. As such, there is a risk that consumers may not be aware of the warnings of an antihistamine in the product that could cause drowsiness.

Consumers who purchased combination packages of Alka-Seltzer Plus Day and Night Cold Formula Liquid Gels from the lot included in this recall (details below) should stop using the product and contact Bayer with any questions or for instructions on a refund or replacement. Consumers should contact our Consumer Relations Call Center at 1(800) 986-3307 (available Monday - Friday 8:30 AM - 5:30PM eastern standard time.) Any consumer with a medical concern or questions should contact their healthcare provider.

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