The Recall Desk
ModerateFDA (Drugs)·D-1136-2017·Announced 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.

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 a voluntary precautionary measure due to a potential risk of contamination, with no reported illnesses or injuries.

Plain-English summary

Mid Valley Pharmaceutical is voluntarily recalling 24 bottles of Doctor Manzanilla Cough & Cold 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. These deviations created a potential risk of product contamination with the bacteria B. cepacia. The source text does not report any illnesses or injuries associated with this recall.

Consumers who have this product should check the lot number and expiration date on their bottles. If the product matches the recalled lot, consumers should stop using it and contact Mid Valley Pharmaceutical for further instructions.

The recalled product

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.
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 →

Same manufacturer · Mid Valley Pharmaceutical

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