Why it was recalled
Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.
Product description
Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 41616-638-68, UPC 3 41616 63868 4.
Lot numbers, UPCs & expiration codes
Lot #s: JKP2234A, JKP2235A, Exp 04/17
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0735-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 11, 2016
- FDA report date
- Mar 9, 2016
- Quantity
- 381,120 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sun Pharma Global Fze
Original FDA data
Every field from FDA enforcement report D-0735-2016, exactly as published.
Show all FDA fields
- City
- Sharm
- Status
- Terminated
- Country
- United Arab Emirates
- Event ID
- 73420
- Address
- Office # 43 Block Y Saif Zone
- Code information
- Lot #s: JKP2234A, JKP2235A, Exp 04/17
- Report date
- Mar 9, 2016
- Product type
- Drugs
- Recall number
- D-0735-2016
- Classification
- Class II
- Recalling firm
- Sun Pharma Global Fze
- Product quantity
- 381,120 cartons
- Termination date
- May 23, 2017
- Reason for recall
- Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 41616-638-68, UPC 3 41616 63868 4.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Feb 11, 2016
- Initial firm notification
- Center classification date
- Mar 3, 2016