The Recall Desk
ModerateFDA (Drugs)·D-1135-2017·Announced 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.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and is described as a precautionary measure due to a potential risk of contamination, fitting the criteria for a voluntary precautionary recall with low-risk contamination.

Plain-English summary

Mid Valley Pharmaceutical is recalling 24 bottles of Doctor Manzanilla Allergy & Decongestant Relief syrup. The product is a 4 fl oz (118 mL) bottle containing diphenhydramine hydrochloride and phenylephrine hydrochloride. The specific lot number is 23221701, with an expiration date of 05/19. The product was distributed in Texas.

The recall was initiated as a precautionary measure due to Current Good Manufacturing Practice (CGMP) deviations. There is a potential risk that the product may be contaminated with the bacteria B. cepacia. The agency classifies this as a Class II recall.

Consumers who have this product should stop using it and contact Mid Valley Pharmaceutical for instructions on how to return or dispose of the medication.

The recalled product

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.
Manufacturer
Mid Valley Pharmaceutical
Category
Drug — Syrup
Hazard
Affected units
24

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot: 23221701
  • Exp. 05/19

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by Mid Valley Pharmaceutical under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Mid Valley Pharmaceutical

See all →

Same hazard · bacterial contamination

See all →