Why it was recalled
Superpotent Drug: High out of specification results for assay at the 6 month time point interval.
Product description
col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-count, item 351104, UPC 0 11822 51104 9; and b) 60-count, item 357392, UPC 0 11822 57392 4; DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL , PA 17011.
Lot numbers, UPCs & expiration codes
Lot #: 5C344105, Exp 02/17
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-0856-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 29, 2016
- FDA report date
- May 25, 2016
- Quantity
- a) 9816 bottles; b) 9648 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Allegiant Health
Original FDA data
Every field from FDA enforcement report D-0856-2016, exactly as published.
Show all FDA fields
- City
- Deer Park
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 73569
- Address
- 75 N Industry Ct
- Code information
- Lot #: 5C344105, Exp 02/17
- Postal code
- 11729-4601
- Report date
- May 25, 2016
- Product type
- Drugs
- Recall number
- D-0856-2016
- Classification
- Class III
- Recalling firm
- Allegiant Health
- Product quantity
- a) 9816 bottles; b) 9648 bottles
- Termination date
- Jun 6, 2018
- Reason for recall
- Superpotent Drug: High out of specification results for assay at the 6 month time point interval.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-count, item 351104, UPC 0 11822 51104 9; and b) 60-count, item 357392, UPC 0 11822 57392 4; DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL , PA 17011.
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 29, 2016
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- May 17, 2016