Drug recall D-0243-2025
Product
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-760-01.
Reason for recall
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Lots and codes
Lot Numbers: 19233234, 19233253, Exp.: 7/2025; 19234154, Exp.: 9/2025; 19243185, Exp.: 7/2026; 19243951, 19243974, Exp.: 9/2026.
Recall details
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Quantity
- 58,416 bottles
- Distribution
- Nationwide within the U.S
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 29, 2025
Related products
- Atomoxetine – drug information
- NDC 16714-759 Atomoxetine · Atomoxetine Hydrochloride 60 mg/1 · Northstar Rx LLC
- NDC 16714-760 Atomoxetine · Atomoxetine Hydrochloride 80 mg/1 · Northstar Rx LLC
- NDC 16714-757 Atomoxetine · Atomoxetine Hydrochloride 25 mg/1 · Northstar Rx LLC
- NDC 16714-761 Atomoxetine · Atomoxetine Hydrochloride 100 mg/1 · Northstar Rx LLC
- NDC 16714-756 Atomoxetine · Atomoxetine Hydrochloride 18 mg/1 · Northstar Rx LLC
- NDC 16714-755 Atomoxetine · Atomoxetine Hydrochloride 10 mg/1 · Northstar Rx LLC
- NDC 16714-758 Atomoxetine · Atomoxetine Hydrochloride 40 mg/1 · Northstar Rx LLC