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  3. Recall Enforcement Event ID: 64533

Recall Enforment Report D-208-2013

Recall Details

Multi event Drug Recall Enforcement Report Class III voluntary initiated by Novartis Consumer Health, originally initiated on 03-07-2013 for the product Nupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic Ointment, a) 1-oz. tubes (NDC 0067-5812-96), b) 2-oz. tubes (NDC 0067-5812-86), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054. The product was recalled due to labeling: incorrect or missing lot and/or exp date. the lot number and/or expiration date may be illegible.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-208-201303-07-201303-27-2013Class III91,872/1-oz. tubes and 94,464/2-oz. tubesNupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic Ointment, a) 1-oz. tubes (NDC 0067-5812-96), b) 2-oz. tubes (NDC 0067-5812-86), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.Terminated
D-211-201303-07-201303-27-2013Class III227,124 bottles4 way Saline Moisturizing Mist with Eucalyptol & Menthol, 1-fl. oz. bottles, OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.Terminated
D-210-201303-07-201303-27-2013Class III44,604/ .5-fl. oz. bottles and 439,452 /1-fl. oz. bottles4 way Nasal Decongestant Menthol Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2087-05) b) 1-fl. oz. bottles (NDC 0067-2087-01), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.Terminated
D-207-201303-07-201303-27-2013Class III240,120/2-oz. tubes and 429,144/4-oz. tubesMyoflex (trolamine salicylate) 10%, Pain Relieving Cream, a) 2-oz tube, b) 4-oz. tube, OTC. The firm name on the label is Novartis Consumer Health, Inc., Parsippany, NJ 07054.Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.Terminated
D-209-201303-07-201303-27-2013Class III538,092/.5-fl. oz. bottles, 1,186,740/1-oz. bottles, and 138,528/1.25-fl. oz bottles4 way Nasal Decongestant Fast Acting Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2086-05), b) 1-fl. oz. bottles (NDC 0067-2086-01), c) 1.25-fl. oz. bottles (NDC 0067-2086-15), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0067-20864 Way Fast ActingPhenylephrine HydrochlorideSprayNasalHaleon Us Holdings LlcHuman Otc Drug