Drug recall

Benadryl (Diphenhydramine HCl) Allergy tablets, 25 mg each, 100 Ultratab bottle, OTC, Distributed by: McNeil…

FDA recall event 56146 · Class II · Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc.

Key facts

Event ID 56146
Recall numbers D-715-2010, D-716-2010, D-717-2010, D-718-2010, D-719-2010, D-720-2010, D-721-2010, D-722-2010, D-723-2010, D-724-2010
Recalling firm Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc.
Product type Drugs
Products Benadryl (Diphenhydramine HCl) Allergy tablets, 25 mg each, 100 Ultratab bottle, OTC, Distributed by: McNeil Consumer Health, DIVISION OF MCNEIL-PPC, INC., FORT WASHINGTON, PA 19034 USA, NDC…, Children's Tylenol (Acetaminophen) Tablets, Meltaways, Bubblegum Burst flavor, 80 mg, 30 count bottle, OTC, Distributed by: McNeil Consumer Health, DIVISION OF MCNEIL-PPC, INC., FORT WASHINGTON, PA…, Motrin IB (Ibuprofen) Caplets, USP 200 mg, a) 24 count bottle, NDC 50580-110-03, UPC 3 0045 0481 030; b) Bonus pack (50+ 25) count bottle, NDC 50580-110-76, UPC 3 0045 0481 764; OTC, Distributed by…, Motrin IB (Ibuprofen) Tablets USP 200 mg, 100 count bottle, OTC, Distributed by: McNeil Consumer Health, DIVISION OF MCNEIL-PPC, INC., FORT WASHINGTON, PA 19034 USA, NDC 50580-109-04, UPC 3 0045 0463…, Tylenol (Acetaminophen) Caplets, Extra Strength, 500 mg each a) 24 count bottle, NDC 50580-710-24, UPC 3 0045-0444-240, b) 24+12 count bottle, NDC 50580-449-31, UPC 3 0045-0444-318, c) 50 count… and 5 more
Classification Class II
Status Terminated
Voluntary or mandated Firm Initiated
Reason for recall Chemical Contamination: presence of a chemical called 2,4,6-tribromoanisole (TBA) in products
Initiation date Jul 8, 2010
Termination date Sep 30, 2012
City Fort Washington
State PA
Country United States
FEI number 2510184

At a glance

  • 10–99 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.

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Source: U.S. Food and Drug Administration (FDA), Enforcement Reports

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