Published recall report · ImpurityUpdated · 9 months ago
Cipla USA, Inc. recall: Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02
Current recall status is unverified. FDA does not update drug-enforcement status after publication. Check the latest official information or ask a pharmacist.
What to do
Check the lot number on your pack against this recall and follow the firm's instructions. Do not stop taking a prescribed medicine without talking to a pharmacist or doctor first.
FDA public enforcement report, opens in a new tabWhich products
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02
- Producer
- Cipla USA, Inc.
- Brand
- CINACALCET
4PB0109
- Dates on pack
- Lot, expiry: Lot 4PB0109, exp 1/31/2026; Lot 5PB0172, exp 1/31/2027
5PB0172
- Dates on pack
- Lot, expiry: Lot 4PB0109, exp 1/31/2026; Lot 5PB0172, exp 1/31/2027
More detail
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
In the news
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