Class I - Dangerous
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
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Over-the-Counter
💊 Drugs • 328 recalls
Class I - Dangerous
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class I - Dangerous
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class I - Dangerous
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class I - Dangerous
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class I - Dangerous
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class I - Dangerous
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class I - Dangerous
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class I - Dangerous
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
"Well at Wallgreens" Regular Strength Antacid Liquid (Alumina/Magnesia/Simethicone/Antacid & Anti Gas); Mint, a)12 oz bottle (NDC 0363-0073-02), b) 26 oz. bottle (NDC 0363-0073-26), Distributed by Walgreens CO., 200 Wilmot Rd, Deerfield, IL 60015.
Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count outside of specifications and E. Coli contamination.
Class I - Dangerous
Subpotent Drug: Product did not conform to the 18-month stability test specification for active Free Benzocaine.
Class I - Dangerous
Subpotent; 12 month time point for the active ingredient Phenylephrine HCl.
4 way Saline Moisturizing Mist with Eucalyptol & Menthol, 1-fl. oz. bottles, OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.
Novartis Consumer Health
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
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.
Novartis Consumer Health
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Myoflex (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.
Novartis Consumer Health
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Class I - Dangerous
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Class I - Dangerous
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Class I - Dangerous
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.