Why it was recalled
Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia
Product description
Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby Laboratories, Livonia, MI --- NDC 0536-0590-85
Lot numbers, UPCs & expiration codes
20351407, 20351408, exp 09/16; 20351409, exp 11/16; 20351410, exp 12/16; 20351501, 20351502, exp 01/17; 20351503, exp 03/17; 20351504, exp 04/17; 20351505, exp 05/17; 20351506, 20351507, exp 06/17; 20351508, exp 07/17, 20351509, 20351510, exp 10/17; 20351511, 20351512, 20351513, exp 11/17; 20351601, exp 01/18; 20351602, exp 02/18; 20351603, exp 03/18; 20351604, 20351605, exp 04/18
Where it was sold
Nationwide
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-0022-2017
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jul 15, 2016
- FDA report date
- Oct 19, 2016
- Quantity
- 153,432 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Harvard Drug Group
Original FDA data
Every field from FDA enforcement report D-0022-2017, exactly as published.
Show all FDA fields
- City
- Livonia
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 74723
- Address
- 31778 Enterprise Dr
- Code information
- 20351407, 20351408, exp 09/16; 20351409, exp 11/16; 20351410, exp 12/16; 20351501, 20351502, exp 01/17; 20351503, exp 03/17; 20351504, exp 04/17; 20351505, exp 05/17; 20351506, 20351507, exp 06/17; 20351508, exp 07/17, 20351509, 20351510, exp 10/17; 20351511, 20351512, 20351513, exp 11/17; 20351601, exp 01/18; 20351602, exp 02/18; 20351603, exp 03/18; 20351604, 20351605, exp 04/18
- Postal code
- 48150-1960
- Report date
- Oct 19, 2016
- Product type
- Drugs
- Recall number
- D-0022-2017
- Classification
- Class I
- Recalling firm
- The Harvard Drug Group
- Product quantity
- 153,432 bottles
- Termination date
- Mar 27, 2017
- Reason for recall
- Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby Laboratories, Livonia, MI --- NDC 0536-0590-85
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 15, 2016
- Initial firm notification
- Press Release
- Center classification date
- Oct 12, 2016