Why it was recalled
Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.
Product description
Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 50268-061-11] per carton [NDC 50268-061-15], Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478
Lot numbers, UPCs & expiration codes
Lot: 19900, exp 05/2019
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-0544-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 9, 2018
- FDA report date
- Mar 7, 2018
- Quantity
- 630 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apace KY LLC
Original FDA data
Every field from FDA enforcement report D-0544-2018, exactly as published.
Show all FDA fields
- City
- Fountain Run
- State
- KY
- Status
- Terminated
- Country
- United States
- Event ID
- 79194
- Address
- 12954 Fountain Run Rd
- Code information
- Lot: 19900, exp 05/2019
- Postal code
- 42133-7914
- Report date
- Mar 7, 2018
- Product type
- Drugs
- Recall number
- D-0544-2018
- Classification
- Class II
- Recalling firm
- Apace KY LLC
- Product quantity
- 630 cartons
- Termination date
- Sep 10, 2019
- Reason for recall
- Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 50268-061-11] per carton [NDC 50268-061-15], Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 9, 2018
- Initial firm notification
- Letter
- Center classification date
- Feb 23, 2018