Why it was recalled
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Product description
Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-7718-05) b) 30-count blister card (NDC 0615-7718-39), Rx only, Mfd By Pliva HRVATSKA for Teva USA, PKG by Vangard Glasgow, KY 42141.
Lot numbers, UPCs & expiration codes
Lot#: a) 7718-3008, Exp 08/31/2024; b) 7718-3008, Exp 08/31/2024
Where it was sold
Nationwide USA
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-0113-2024
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 27, 2023
- FDA report date
- Nov 29, 2023
- Quantity
- 1,344 cards
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- NCS Healthcare of Kentucky Inc
Original FDA data
Every field from FDA enforcement report D-0113-2024, exactly as published.
Show all FDA fields
- City
- Glasgow
- State
- KY
- Status
- Terminated
- Country
- United States
- Event ID
- 93336
- Address
- 120 Carroll Knicely Dr
- Code information
- Lot#: a) 7718-3008, Exp 08/31/2024; b) 7718-3008, Exp 08/31/2024
- Postal code
- 42141-7224
- Report date
- Nov 29, 2023
- Product type
- Drugs
- Recall number
- D-0113-2024
- Classification
- Class III
- Recalling firm
- NCS Healthcare of Kentucky Inc
- Product quantity
- 1,344 cards
- Termination date
- Jul 14, 2024
- Reason for recall
- Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-7718-05) b) 30-count blister card (NDC 0615-7718-39), Rx only, Mfd By Pliva HRVATSKA for Teva USA, PKG by Vangard Glasgow, KY 42141.
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Oct 27, 2023
- Initial firm notification
- Letter
- Center classification date
- Nov 21, 2023