Why it was recalled
Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate Sodium 100mg softgel caps.
Product description
Docusate Sodium, 100mg softgels, packaged in 10 x 10 unit dose blister cards, For institutional use only, Mfg by: Aenova Holding GmBh, Miami, Fl 33186, NDC 63739-0478-10
Lot numbers, UPCs & expiration codes
Lot # 0119397, Exp 02/2020
Where it was sold
Product was distributed to 5 major distributors who may have further distributed the product throughout the United States.
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-1007-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 16, 2019
- FDA report date
- Mar 27, 2019
- Quantity
- 29,622 Blister Cards
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Rx Pak Division of McKesson Corporation
Original FDA data
Every field from FDA enforcement report D-1007-2019, exactly as published.
Show all FDA fields
- City
- Memphis
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 81943
- Address
- 4971 Southridge Blvd Ste 111-115
- Code information
- Lot # 0119397, Exp 02/2020
- Postal code
- 38141-8300
- Report date
- Mar 27, 2019
- Product type
- Drugs
- Recall number
- D-1007-2019
- Classification
- Class II
- Recalling firm
- Rx Pak Division of McKesson Corporation
- Product quantity
- 29,622 Blister Cards
- Termination date
- Dec 2, 2020
- Reason for recall
- Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate Sodium 100mg softgel caps.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Docusate Sodium, 100mg softgels, packaged in 10 x 10 unit dose blister cards, For institutional use only, Mfg by: Aenova Holding GmBh, Miami, Fl 33186, NDC 63739-0478-10
- Distribution pattern
- Product was distributed to 5 major distributors who may have further distributed the product throughout the United States.
- Recall initiation date
- Jan 16, 2019
- Initial firm notification
- Letter
- Center classification date
- Mar 15, 2019