Cipla

Cipla USA is recalling Cinacalcet Hydrochloride 90 mg tablets (lot 5PB0563, expiring 4/30/2027) because they contain elevated levels of N-nitroso-cinacalcet, a potentially harmful impurity that exceeds acceptable daily intake limits. This is a manufacturing quality issue.

Cipla USA is recalling certain batches of Cinacalcet Hydrochloride 60 mg tablets because they contain N-nitroso-cinacalcet, a chemical impurity, at levels above the FDA's acceptable daily intake. The affected lots were distributed nationwide. No injuries have been reported.

Cipla USA is recalling specific lots of Cinacalcet Hydrochloride 30 mg tablets because they contain elevated levels of N-nitroso-cinacalcet, a manufacturing impurity that exceeds FDA safety limits. The affected bottles were distributed nationwide.

Cipla USA is recalling certain batches of cinacalcet 90 mg tablets because they contain higher-than-safe levels of a chemical impurity called N-Nitroso Cinacalcet. The affected bottles were distributed nationwide. No injuries have been reported.

Cipla USA is recalling specific lots of Cinacalcet Hydrochloride 60 mg tablets because they contain higher-than-acceptable levels of N-Nitroso Cinacalcet, a nitrosamine impurity. This impurity can pose a health risk with long-term exposure. The affected lots were distributed nationwide.

Cipla USA is recalling specific lots of Cinacalcet Hydrochloride 30 mg tablets because they contain higher-than-acceptable levels of a chemical impurity called N-Nitroso Cinacalcet. The affected tablets were distributed nationwide. This is a manufacturing quality issue; no injuries have been reported.

Cipla USA is recalling specific lots of Lanreotide Injection (120 mg) because the manufacturer did not follow proper visual inspection procedures during production. This means the medication may not meet sterility standards and could potentially be contaminated.

Cipla USA is recalling specific lots of Lanreotide Injection 120 mg due to concerns about sterility. The FDA found deficiencies in the manufacturer's visual inspection procedures, which could mean some syringes may not be properly sterilized. No injuries have been reported so far.

Cipla USA is recalling Nilotinib 200 mg capsules (Lot 5GJ0223, expiring 04/30/2027) because the capsules failed quality tests during stability testing. The capsules may not meet appearance and description standards, which means their safety and effectiveness cannot be guaranteed.

Cipla USA is recalling specific lots of Nilotinib 150 mg capsules because testing found the capsules did not meet appearance and description standards after six months of storage. The affected lots are 5GJ0220, 5GJ0221, and 5GJ0222, with expiration date 04/30/2027. No injuries have been reported.

Cipla USA is recalling Diclofenac Sodium Topical Gel 1% (batch XHBG, expiring 08/31/2027) because it failed to meet required pH specifications during quality testing. The gel may not work as intended or could cause skin irritation. No injuries have been reported so far.

Cipla USA is recalling certain pre-filled syringes of Lanreotide Injection 120 mg because they may contain particulate matter (small particles) in the solution. The affected syringes have specific lot numbers and expiration dates between October 2026 and March 2027. No injuries have been reported so far.

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Failed stability specifications: Out of specification for hardness test

Failed stability specifications: Out of specification for hardness test

Failed Stability Specifications: Observed OOS results: eg results for colour index