Drug recall
EXTRA STRENGTH Rolaids Antiacid (Calcium Carbonate & Magnesium Hydroxide) FRESGMINT Tablets, 675 mg/135mg…
FDA recall event 54273 · Class II · McNeil Consumer Healthcare, Div of McNeil-PPC, Inc.
Key facts
| Event ID | 54273 |
|---|---|
| Recall numbers | D-498-2010, D-499-2010, D-500-2010, D-501-2010, D-502-2010, D-503-2010 |
| Recalling firm | McNeil Consumer Healthcare, Div of McNeil-PPC, Inc. |
| Product type | Drugs |
| Products | EXTRA STRENGTH Rolaids Antiacid (Calcium Carbonate & Magnesium Hydroxide) FRESGMINT Tablets, 675 mg/135mg, 100-count bottle, NDC 50580-746-01, UPC 312547650212, OTC, Distributed by: MCNEIL-PPC, INC…, EXTRA STRENGTH Rolaids Antiacid (Calcium Carbonate & Magnesium Hydroxide) Fruit Tablets, 675 mg/135mg, 100-count bottle, NDC 50580-744-01, UPC 312547650243, OTC, Distributed by: MCNEIL-PPC, INC., FORT…, EXTRA STRENGTH Rolaids Antiacid (Calcium Carbonate & Magnesium Hydroxide) Tropical Punch Tablets, 675 mg/135mg, 100-count bottle, NDC 50580-745-01, UPC 312547654234, OTC, Distributed by: MCNEIL-PPC…, ORIGINAL Rolaids Antiacid (Calcium Carbonate & Magnesium Hydroxide) Peppermint Tablets, 550 mg / 110 mg, 150-count bottle, NDC 50580-772-15, UPC 312547651185, OTC, Distributed by: MCNEIL-PPC, INC…, Rolaids Antiacid (Calcium Carbonate & Magnesium Hydroxide) Cherry Tablets, 550mg / 110mg, 150-count bottle, NDC 50580-773-15, UPC 312547652421, OTC, Distributed by: MCNEIL-PPC, INC., FORT WASHINGTON… and 1 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Chemical Contamination: The product recall was initiated after identifying an uncharacteristic smell and taste associated with the presence of a chemical called 2,4,6,-tribromoanisole. The source of…, Chemical Contamination: The product recall was initiated after identifying an uncharacteristic smell and taste associated with the presence of a chemical called 2,4,6,-tribromoanisole. The source of… |
| Initiation date | Jan 15, 2010 |
| Termination date | Jun 10, 2014 |
| City | Fort Washington |
| State | PA |
| Country | United States |
| FEI number | 2510184 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports