Class III
Terminated
Altavera Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg and 0.03 mg, Rx only, 3 tablet dispensers x 28 tablets. Manufactured by Laboratories Leon Farma S.A., Spain, for Xiromed, LLC., Florham Park, NJ 07932. Product of Spain NDC 70700-116-85 (I unit x 28 tablets 70700-116-84)
- Company
- Xiromed Llc
- Recall Initiated
- September 18, 2018
- Posted
- October 17, 2018
- Recall Number
- D-0016-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 40064 3x28 units
- Firm Location
- Florham Park, NJ, United States
Reason for Recall
Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.
Distribution
Nationwide in the USA
Lot / Code Info
Lots: LF11838A Expiry May 2020; LF12107A, LF12106A, Expiry June 2020
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