Recalls / Class II
Class IID-0428-2019
Product
Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC 0378-0782-05); Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA.
- Affected lot / code info
- Lot #: a) 3085490, 3085491, Exp 04/19; b) 3085492, 3085493, 3085494, 3085495, 3085496, Exp 04/19
Why it was recalled
Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, N/A, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 88,090 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-01-18
- FDA classified
- 2019-02-04
- Posted by FDA
- 2019-02-06
- Terminated
- 2019-10-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0428-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.