Pitavastatin 2 mg bottle found to contain a 1 mg tablet
Annora Pharma is recalling one lot of Pitavastatin Tablets 2 mg after one Pitavastatin 1 mg tablet was found in a bottle of 2 mg tablets.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The rubric places FDA Class III recalls at 1 or 2, and this concerns a single lower-strength tablet of the same medicine found in one bottle, with no hazard or injury stated.
Plain-English summary
Annora Pharma Private Limited is recalling Pitavastatin Tablets, 2 mg, in 90-count bottles, prescription only, made for Northstar Rx LLC of Memphis, Tennessee, NDC 72603-479-01. About 770 bottles were distributed in Tennessee. The FDA has classified this recall as Class III.
The recall was initiated for the presence of foreign tablets or capsules: one Pitavastatin 1 mg tablet was found in a bottle of Pitavastatin 2 mg tablets.
Affected product is lot A252487 with an expiry date of 05/31/2027.
Patients and pharmacies can identify affected product by the NDC and lot number above, and may contact Annora Pharma Private Limited for further information.
The recalled product
- Product
- PITAVASTATIN CALCIUM (PITAVASTATIN CALCIUM)
- Brand
- PITAVASTATIN CALCIUM
- Manufacturer
- Annora Pharma Private Limited
- Category
- Drug — Prescription tablet
- Affected units
- 770
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: A252487
- Exp 05/31/2027
Distribution
Distributed in 1 state:
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