Why it was recalled
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot: 23221701, Exp. 05/19
Where it was sold
TX
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1135-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 30, 2017
- FDA report date
- Sep 20, 2017
- Quantity
- 24 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mid Valley Pharmaceutical
Original FDA data
Every field from FDA enforcement report D-1135-2017, exactly as published.
Show all FDA fields
- City
- Raymondville
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 78049
- Address
- 910 E Hidalgo Ave
- Address (line 2)
- Suite 3
- Code information
- Lot: 23221701, Exp. 05/19
- Postal code
- 78580-4095
- Report date
- Sep 20, 2017
- Product type
- Drugs
- Recall number
- D-1135-2017
- Classification
- Class II
- Recalling firm
- Mid Valley Pharmaceutical
- Product quantity
- 24 bottles
- Termination date
- May 7, 2020
- Reason for recall
- CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- TX
- Recall initiation date
- Aug 30, 2017
- Initial firm notification
- Press Release
- Center classification date
- Sep 11, 2017