Hetero Labs, Ltd. - Unit III recalls Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) bottle, Rx only, Manufactured for: Camber…
- Recall date
- October 12, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0099-2018
- FDA classification
- Class II
- Brand / firm
- Hetero Labs, Ltd. - Unit III
- Sold / distributed
- NJ
Why it was recalled
Presence of foreign substance (screw)
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Jeedimetla,Hyderabad - 500 055, India, NDC 31722-574-47
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