Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Reason CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Reason Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17.
Reason Labeling:Label Mixup; RAMIPRIL, Capsule, 2.5 mg, Rx only may be potentially mislabeled as PROPAFENONE HCL, Tablet, 150 mg, NDC 00591058201…
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