Exact FDA event identifier

Event 65840

9 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: August 06, 2013
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Novartis Consumer Health

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

9 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 9

Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorted Fruit flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, DIN 02243496, UPC 0 58478 44872 5.

D-902-2013

Recall number: D-902-2013
Initiated: August 06, 2013
Classification: Class III
Status: Terminated
Recalling firm: Novartis Consumer Health
Quantity: 117,816 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Incorrect Or Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.

Code information

Lot #: 10097345, Exp 08/13; 10104668, Exp 01/14; 10114317, Exp 03/14; 10120624, Exp 07/14

Distribution pattern

Nationwide, Canada, and Panama.

drug · product 2 of 9

Maalox Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wild Berry flavor, packaged in a) 50-count (UPC 0 58478 44825 1), b) 100-count (UPC 0 58478 44826 8) and c) 145-count (UPC 0 58478 44836 7) tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 02238290.

D-903-2013

Recall number: D-903-2013
Initiated: August 06, 2013
Classification: Class III
Status: Terminated
Recalling firm: Novartis Consumer Health
Quantity: 112,728 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Incorrect Or Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.

Code information

Lot #: a) 10095538, Exp 07/13; 10099449, Exp 09/13; 10104663, Exp 01/14; 10111110, Exp 02/14; 10114312, Exp 04/14; 10120619, Exp 07/14; b) 10095537, Exp 07/13; 10099451, Exp 09/13; 10104664, Exp 01/14; 10111112, Exp 02/14; 10114313, Exp 04/14; 10120620, Exp 07/14; c) 10095528, Exp 07/13; 10106998, Exp 01/14; 10120618, Exp 07/14

Distribution pattern

Nationwide, Canada, and Panama.

drug · product 3 of 9

Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Wild Berry flavor, 65-count tablets per bottle, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-62791-65, UPC 3 0067-0376-65 9.

D-904-2013

Recall number: D-904-2013
Initiated: August 06, 2013
Classification: Class III
Status: Terminated
Recalling firm: Novartis Consumer Health
Quantity: 410,220 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Incorrect Or Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.

Code information

Lot #: 10093113, Exp 06/13; 10097332, Exp 08/13; 10101258, Exp 10/13; 10104632, Exp 12/13; 10108852, Exp 01/14; 10104633, 10110688, Exp 02/14; 10111944, Exp 03/14; 10114325, Exp 05/14; 10120609, 10120610, Exp 07/14; 10123084, Exp 09/14

Distribution pattern

Nationwide, Canada, and Panama.

drug · product 4 of 9

Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorted Fruit flavor, packaged in a) 35-count (NDC 0067-6279-35) (UPC 3 0067-0343-35 4); b) 65-count (NDC 0067-6279-65) (UPC 3 0067-0343-65 1); and c) 90-count (NDC 0067-6279-90) (UPC 3 0067-0343-90 3) tablets per bottle, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622.

D-905-2013

Recall number: D-905-2013
Initiated: August 06, 2013
Classification: Class III
Status: Terminated
Recalling firm: Novartis Consumer Health
Quantity: 3,451,224 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Incorrect Or Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.

Code information

Lot #: a) 10090971, Exp 08/13; 10101253, Exp 09/13; 10102751, Exp 11/13; 10104624, Exp 01/14; 10108954, 10108955, Exp 02/14; 10111942, 10111943, Exp 03/14, 10117575, Exp 04/14; b) 10095525, Exp 07/13; 10097329, Exp 08/13; 10099437, 10101254, Exp 09/13; 10101255, 10102752, Exp 10/13; 10104625, 10104626, Exp 11/13; 10104627, 10109871, 10110711, 10109182, Exp 01/14; 10109872, 10110003, Exp 02/14; 10111941, Exp 03/14; 10115413, 10116855, Exp 04/14; 10118565, 10118566, Exp 06/14; 10120611, 10120612, Exp 07/14; 10123086, Exp 08/14; c) 10093109, 10093111, 10093112, Exp 06/13; 10095529, 10095540, Exp 07/13; 10097330, 10097331, Exp 08/13; 10099438, 10099439, 10099440, Exp 09/13; 10101256, 10101257, Exp 10/13; 10102753, 10102754, 10104628, Exp 11/13; 10104629, Exp 12/13; 10104630, 10104631, 10108289, 10108290, Exp 01/14; 10107564, 10109868, 10110004, 10110005, Exp 02/14; 10111938, 10111939, 10113621, 10113622, 10114320, 10114321, Exp 03/14; 10114322, 10114323, 10116852, Exp 04/14; 10116853, Exp 05/14; 10118563, 10118564, Exp 06/14; 10120613, 10120614, Exp 07/14; 10123087, 10123088, 10123089, Exp 08/14; 10126000, 10126001, 10126002, Exp 09/14; 10128831, 10128833, Exp 10/14

Distribution pattern

Nationwide, Canada, and Panama.

drug · product 5 of 9

Maalox Extra Strength Antacid (calcium carbonate) chewable tablets,1000 mg, Wild Berry flavor, packaged in a) 35-count (UPC 0 58478 44829 9) and b) 65-count (UPC 0 58478 44842 8) tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 02238291.

D-906-2013

Recall number: D-906-2013
Initiated: August 06, 2013
Classification: Class III
Status: Terminated
Recalling firm: Novartis Consumer Health
Quantity: 149,616 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Incorrect Or Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.

Code information

Lot #: a) 10095535, Exp 07/13; 10101288, Exp 10/13; 10104665, Exp 01/14; 10111114, Exp 02/14; 10114314, Exp 04/14; 10120621, Exp 07/14; b) 10095536, Exp 07/13; 10101289, Exp 10/13; 10104666, Exp 01/14; 10111116, Exp 02/14; 10114315, Exp 04/14; 10120622, Exp 07/14

Distribution pattern

Nationwide, Canada, and Panama.

drug · product 6 of 9

Maalox, Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wintergreen flavor, 50-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 02238290, UPC 0 58478 44824 4.

D-907-2013

Recall number: D-907-2013
Initiated: August 06, 2013
Classification: Class III
Status: Terminated
Recalling firm: Novartis Consumer Health
Quantity: 46,680 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Incorrect Or Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.

Code information

Lot #: 10095534, Exp 07/13; 10114311, Exp 04/14

Distribution pattern

Nationwide, Canada, and Panama.

drug · product 7 of 9

Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 600 mg/60 mg, Wild Berry flavor, 35-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, DIN 02243496, UPC 0 58478 44840 4.

D-908-2013

Recall number: D-908-2013
Initiated: August 06, 2013
Classification: Class III
Status: Terminated
Recalling firm: Novartis Consumer Health
Quantity: 129,048 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Incorrect Or Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.

Code information

Lot #: 10093133, Exp 06/13; 10099452, Exp 09/13; 10104667, Exp 12/13; 10110926, Exp 02/14; 10114316, Exp 04/14; 10120623, Exp 07/14; 10123098, Exp 09/14

Distribution pattern

Nationwide, Canada, and Panama.

drug · product 8 of 9

Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablets, 500 mg/200 mg, Mint flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 80000899, UPC 0 58478 10091 3.

D-909-2013

Recall number: D-909-2013
Initiated: August 06, 2013
Classification: Class III
Status: Terminated
Recalling firm: Novartis Consumer Health
Quantity: 23,856 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Incorrect Or Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.

Code information

Lot #: 10107000, Exp 07/13; 10114319, Exp 01/14

Distribution pattern

Nationwide, Canada, and Panama.

drug · product 9 of 9

Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablets, 500 mg/200 mg, Cherry flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 80000899, UPC 0 58478 10090 6.

D-910-2013

Recall number: D-910-2013
Initiated: August 06, 2013
Classification: Class III
Status: Terminated
Recalling firm: Novartis Consumer Health
Quantity: 11,760 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Incorrect or Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.

Code information

Lot #: 10114318, Exp 01/14

Distribution pattern

Nationwide, Canada, and Panama.