Hetero USA Recalls Acyclovir Tablets Due to Human Hair Presence
Hetero USA Inc. is recalling 13,692 bottles of Acyclovir 800 mg tablets because human hair was found melded into the tablets.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for minor defects or documentation issues.
Plain-English summary
Hetero USA Inc. is recalling 13,692 bottles of Acyclovir Tablets, USP, 800 mg, 100-count. The product is a prescription-only medication manufactured for Camber Pharmaceuticals, Inc. by Hetero Labs Limited in India. The specific lot affected is # ACY16075 with an expiration date of 09/2018.
The recall was initiated due to the presence of a foreign substance, specifically human hair, that was melded into the tablets. The agency classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for the specific NDC 31722-778-01 and lot number ACY16075. If found, the product should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- ACYCLOVIR (ACYCLOVIR)
- Brand
- ACYCLOVIR
- Manufacturer
- Hetero USA Inc
- Category
- Drug — Prescription Drug
- Affected units
- 13,692
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # ACY16075 Exp. 09/2018
UPCs (2)
- 0331722777018
- 0331722778015
Distribution
Distributed nationwide across the United States.
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