Why it was recalled
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Product description
Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1001-85, Manufactured by PharmaTech LLC, Davie, FL
Lot numbers, UPCs & expiration codes
All lots remaining within expiry.
Where it was sold
MI
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-0225-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 16, 2017
- FDA report date
- Jan 24, 2018
- Quantity
- Unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmatech LLC
Original FDA data
Every field from FDA enforcement report D-0225-2018, exactly as published.
Show all FDA fields
- City
- Davie
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 77960
- Address
- 4131 SW 47th Ave Ste 1403
- Code information
- All lots remaining within expiry.
- Postal code
- 33314-4036
- Report date
- Jan 24, 2018
- Product type
- Drugs
- Recall number
- D-0225-2018
- Classification
- Class II
- Recalling firm
- Pharmatech LLC
- Product quantity
- Unknown
- Termination date
- Jan 4, 2023
- Reason for recall
- Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1001-85, Manufactured by PharmaTech LLC, Davie, FL
- Distribution pattern
- MI
- Recall initiation date
- Aug 16, 2017
- Initial firm notification
- Letter
- Center classification date
- Jan 17, 2018