Drug recall: Acyclovir Tablets, USP, 800 mg, 100-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, N

FDA enforcement event 77122 · Class III · initiated 27 Apr 2017 · status Terminated · terminated 13 Dec 2017

DrugVoluntary: Firm initiated1 product recordPiscataway, NJ

Hetero USA Inc (Piscataway, NJ) initiated this drug recall on 27 Apr 2017; FDA lists 1 product record under event 77122, classified Class III.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 30% of the 343 drug enforcement events initiated in 2017 carry the same class.

Status: Terminated, terminated 13 Dec 2017. Initiation: voluntary: firm initiated. Hetero USA Inc has 4 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Hetero USA Inc, Piscataway, NJ.

Reason for recall

"Presence of Foreign Substance: human hair melded into tablet."

Distribution

"Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0897-2017	Acyclovir Tablets, USP, 800 mg, 100-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, by Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC 31722-778-01	13,692 bottles	Class III	Terminated	14 Jun 2017

Context

30%of 2017 drug events are Class III343 events that year

1product record in this eventfirm median: 1

4events on this register for the firm

Other enforcement events for Hetero USA Inc

Initiated	Product (first record)	Type	Class	Records
14 Mar 2023	Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceutic	Drug	Class II	1
20 Jul 2017	Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway,	Drug	Class II	1
7 Jan 2017	Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway,	Drug	Class III	1

All 4 events for Hetero USA Inc

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Presence of Foreign Substance: human hair melded into tablet."

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 13 Dec 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.