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
Reported: February 14, 2018 Initiated: January 10, 2018 #D-0594-2018
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
Reason for Recall
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Details
- Recalling Firm
- Hetero Labs, Ltd. - Unit III
- Units Affected
- 3000 bottles
- Distribution
- NJ Only
- Location
- Hyderabad, N/A
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Hetero Labs, Ltd. - Unit III. Units affected: 3000 bottles.
Why was this product recalled? ▼
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 14, 2018. Severity: Moderate. Recall number: D-0594-2018.
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