Why it was recalled
Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
Product description
Saphris 10 mg (asenapine) sublingual tablets, 6x10 count blister packs, Rx only, Black Cherry Flavor, Manufactured by: Catalent UK Swindon, Zydis Ltd, Blagrove, Swindon, Wilshire SN5 BRU, UK Distributed by Forest Pharmaceuticals, Inc. subsidiary of Forest Laboratories, LLC, Cincinnati OH 45209 USA --- NDC 0456-2410-60; Shellpack containing 1 blister card --- NDC 0456-2410-06
Lot numbers, UPCs & expiration codes
Lots W00733 and W00946, exp Apr 2019
Where it was sold
Nationwide
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-0880-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 18, 2017
- FDA report date
- Jun 7, 2017
- Quantity
- 40,621 blister packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Forest Laboratories, LLC
Original FDA data
Every field from FDA enforcement report D-0880-2017, exactly as published.
Show all FDA fields
- City
- Jersey City
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 77315
- Address
- Harborside Financial Center
- Address (line 2)
- Plaza V- Suite 1900
- Code information
- Lots W00733 and W00946, exp Apr 2019
- Postal code
- 07311
- Report date
- Jun 7, 2017
- Product type
- Drugs
- Recall number
- D-0880-2017
- Classification
- Class II
- Recalling firm
- Forest Laboratories, LLC
- Product quantity
- 40,621 blister packs
- Termination date
- Nov 15, 2018
- Reason for recall
- Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Saphris 10 mg (asenapine) sublingual tablets, 6x10 count blister packs, Rx only, Black Cherry Flavor, Manufactured by: Catalent UK Swindon, Zydis Ltd, Blagrove, Swindon, Wilshire SN5 BRU, UK Distributed by Forest Pharmaceuticals, Inc. subsidiary of Forest Laboratories, LLC, Cincinnati OH 45209 USA --- NDC 0456-2410-60; Shellpack containing 1 blister card --- NDC 0456-2410-06
- Distribution pattern
- Nationwide
- Recall initiation date
- May 18, 2017
- Initial firm notification
- Letter
- Center classification date
- May 31, 2017