Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported May 31, 2017
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.
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 repai…
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Mylan Pharmaceuticals Inc. recalled Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fuma… - a low-severity action.
Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fuma… was recalled by Mylan Pharmaceuticals Inc. in May 31, 2017. Reason: Chemical Contamination: out of specification results for impurities were found to be the result of contaminat…. Check the official notice for the remedy. Verify recall #D-0860-2017 with the FDA Drug before acting.
The recall
Mylan Pharmaceuticals Inc. issued this low-severity FDA Drug recall-Chemical Contamination: out of specification results for impurities were found to be the result of contaminat….
- Low
- severity level
- Class III
- classification
- May 31, 2017
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0860-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0860-2017) was formally reported on May 31, 2017, with the manufacturer initiating the action on January 30, 2017. It is classified under Low severity (Class III), with a current status of Terminated. Mylan Pharmaceuticals Inc. is listed as the recalling firm, operating out of Morgantown, WV. Federal records list the affected scope as 43,848 cartons.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Nationwide in USA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
43,848 cartons
Related Recalls
6
5 from same agency
Product description
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.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0860-2017 |
| Date reported | May 31, 2017 |
| Date initiated | January 30, 2017 |
| Recalling firm | Mylan Pharmaceuticals Inc. |
| Firm location | Morgantown, WV |
| Affected scope | 43,848 cartons |
| Distribution | Nationwide in USA |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0860-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Mylan Pharmaceuticals Inc.. Units affected: 43,848 cartons.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 31, 2017. Severity: Low. Recall number: D-0860-2017.
Where was the recalled product distributed? ▼
Distribution: Nationwide in USA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0860-2017) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported May 31, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.