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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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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