Why it was recalled
Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.
Product description
Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30
Lot numbers, UPCs & expiration codes
Lot: DL11600 Exp Date: 06/13
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-1683-2012
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 4, 2012
- FDA report date
- Sep 26, 2012
- Quantity
- 81,516 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apace KY LLC
Original FDA data
Every field from FDA enforcement report D-1683-2012, exactly as published.
Show all FDA fields
- City
- Fountain Run
- State
- KY
- Status
- Terminated
- Country
- United States
- Event ID
- 63080
- Address
- 12954 Fountain Run Rd
- Code information
- Lot: DL11600 Exp Date: 06/13
- Postal code
- 42133-7914
- Report date
- Sep 26, 2012
- Product type
- Drugs
- Recall number
- D-1683-2012
- Classification
- Class III
- Recalling firm
- Apace KY LLC
- Product quantity
- 81,516 bottles
- Termination date
- Jul 10, 2013
- Reason for recall
- Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 4, 2012
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Sep 19, 2012