Why it was recalled
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Product description
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By; Hetero Hetero Labs Limited Unit V Polepallly Jadcheria Mahaboob Nagar - 509 301 India, NDC 31722-827-30
Lot numbers, UPCs & expiration codes
Lot #: ARI17089, ARI17090, Exp. 5/2019
Where it was sold
NJ Only
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-0594-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 10, 2018
- FDA report date
- Feb 14, 2018
- Quantity
- 3000 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hetero Labs, Ltd. - Unit III
Original FDA data
Every field from FDA enforcement report D-0594-2018, exactly as published.
Show all FDA fields
- City
- Hyderabad
- Status
- Terminated
- Country
- India
- Event ID
- 78809
- Address
- Plot 22-110, Part Ii, Ida
- Address (line 2)
- Rangareddy, Jeedimetla
- Code information
- Lot #: ARI17089, ARI17090, Exp. 5/2019
- Report date
- Feb 14, 2018
- Product type
- Drugs
- Recall number
- D-0594-2018
- Classification
- Class II
- Recalling firm
- Hetero Labs, Ltd. - Unit III
- Product quantity
- 3000 bottles
- Termination date
- Sep 21, 2020
- Reason for recall
- CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By; Hetero Hetero Labs Limited Unit V Polepallly Jadcheria Mahaboob Nagar - 509 301 India, NDC 31722-827-30
- Distribution pattern
- NJ Only
- Recall initiation date
- Jan 10, 2018
- Initial firm notification
- Letter
- Center classification date
- Mar 13, 2018