Children's Mapap Acetaminophen Liquid, Fever reducer, Pain reliever, Alcohol free, Aspirin free, Cherry flavored,…

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• Children's Mapap Acetaminophen Liquid, Fever reducer, Pain reliever, Alcohol free, Aspirin free, Cherry flavored, acetaminophen 160 mg per 5 mL, a) 4 FL. oz. (118 mL) bottle, NDC 0904-1985-20, b) One Pint (473 mL) bottle
• NDC
  • 0904-1985-16
  • Distributed by Major Pharmaceuticals
  • Livonia MI 48152

Lot codes and dates

• 100 of 100 codes

  • Lot #s: a) 17E003
  • 17E038
  • Exp. 05/2019
  • 17F002
  • 17F005
  • 17F007
  • 17F025
  • Exp. 06/2019
  • 17G014
  • Exp. 07/2019
  • 17H015
  • Exp. 08/2019
  • 17J004
  • 17J006
  • 17J016
  • Exp. 09/2019
  • 17K008
  • 17K013
  • 17K021
  • 17K027
  • Exp. 10/2019
  • 17L021
  • Exp. 11/2019
  • 17M032
  • Exp. 12/2019
  • 18A023
  • 18A039
  • Exp. 01/2020
  • 18B007
  • 18B030
  • 18B037
  • Exp. 02/2020
  • 18C017
  • 18C026
  • Exp. 03/2020
  • 18D003
  • 18D034
  • Exp. 04/2020
  • 18E027
  • 18E033
  • Exp. 05/2020
  • 18F024
  • 18F033
  • Exp. 06/2020
  • 18G001
  • 18G023
  • Exp. 07/2020
  • 18J008
  • 18J009
  • 18J017
  • 18J027
  • Exp. 09/2020
  • 18K013
  • 18K014
  • 18K028
  • Exp. 10/2020. b) 17E006
  • 17E008
  • Exp. 05/2019
  • 17G001
  • 17G008

  Show all 100 codes

Amount recalled

2,646,228 bottles

This recall covers 41 products

The agency filed one notice per product. You are reading one of them; the other 40 are below.

• RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 13668-589-06…
• Children's Acetaminophen Liquid, 160 mg per 5 mL, Fever and Pain, Alcohol free, aspirin…
• Allergy Liquid Antihistamine, Diphenhydramine HCl USP 12.5 mg/5 mL), Alcohol free, 4…
• Robafen Cough Formula Expectorant (guaifenesin USP 200 mg in each 10 mL), a) 4 Fl. oz.…
• Robafen AC Oral Solution (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100…
• Robafen DM Syrup (Dextromethorphan HBr, USP 20 mg/10 mL and Guaifenesin, USP 200 mg/10…
• Banophen Oral Solution, Sugar Free, Alcohol Free, Cherry Flavor, (Diphenhydramine HCl…
• Pseudoephedrine Oral Solution, 30 mg in each teaspoonful, Nasal Decongestant, One Pint…
• Nasal Decongestant Spray Regular, Oxymetazoline HCl 0.05%, a) 0.5 FL. oz. (15 mL)…
• Robafen DM Cough Sugar-Free Clear Cough Expectorant (Dextromethorphan HBr, USP 20 mg)…
• Pedia Relief Cough-Cold Oral Solution, Alcohol free, antihistamine, cough suppressant…
• Biscolax Laxative (Bisacodyl, USP 10 mg), a) 12 suppositories per carton, NDC…

28 more are in the archive.

Why it was recalled

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

This product could cause temporary or reversible health problems — stop using it.