The Recall Desk

FDA (Drugs) recall action 78049

Mid Valley Pharmaceutical recalled 2 products on 2017-09-20

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2017-09-20
Critical
0
Units
48

Why these products were recalled

CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Drugs)··2017-09-20

    Mid Valley Recalls Doctor Manzanilla Syrup Due to B. cepacia Risk

    Mid Valley Pharmaceutical is recalling 24 bottles of Doctor Manzanilla Allergy & Decongestant Relief syrup due to a potential risk of contamination with B. cepacia bacteria.

    Product
    Doctor Manzanilla Allergy & Decongestant Relief (diphenhydramine hydrochloride and phenylephrine hydrochloride) Syrup, 12.5 mg and 5 mg in each 5 mL, 4 fl oz. (118 mL) bottle, Distributed by: Midvalley Pharmaceuticals, Raymondville, TX 78580, UPC 7 62558 00204 1.
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2017-09-20

    Mid Valley Pharmaceutical Recalls Doctor Manzanilla Cough & Cold Syrup

    Mid Valley Pharmaceutical is recalling Doctor Manzanilla Cough & Cold Syrup due to a potential risk of contamination with B. cepacia bacteria.

    Product
    Doctor Manzanilla Cough & Cold (diphenhydramine hydrochloride and phenylephrine hydrochloride) Syrup, 12.5 mg and 5 mg in each 5 mL, 4 fl oz. (118 mL) bottle, Distributed by: Midvalley Pharmaceuticals, Raymondville, TX 78580, UPC 7 62558 00316 1.
    Category
    Distribution
    1 state