Tarina Fe 1/20 recall: Impurity Out of Spec
Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 1 blister pack containing 28 tablets (NDC 50102-128-01), packaged in 3 pouches, each pouch contains one blister pack of 28 tablets (NDC 50102-128-03), Rx only, Manufactured for: Afaxys, Inc., Charleston, SC 29403, USA, Product of India.
Why was Tarina Fe 1/20 recalled?
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 6843F002D, Exp 02/18
- Product
- Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 1 blister pack containing 28 tablets (NDC 50102-128-01), packaged in 3 pouches, each pouch contains one blister pack of 28 tablets (NDC 50102-128-03), Rx only, Manufactured for: Afaxys, Inc., Charleston, SC 29403, USA, Product of India.
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Quantity
- 43,848 cartons
- Distribution
- Nationwide in USA
- Recall date
- May 31, 2017
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)